Malaysia

 

Policy

Traditional and Complementary medicine is widely use in prevention, treatment and management of diseases. Unregulated or inappropriate use of traditional medicines and practices can have negative or dangerous effects to health and socioeconomics.

The National Policy of traditional and complementary address these issues by developing necessary regulatory and legal mechanism in place in promoting and maintaining good T&CM practice so that public will benefit a safe and  quality services. The National Policy are divided into 4 components; Education &training, Practice, raw material and products, and research.

Traditional medicine practices have developed within different cultures in different regions of Malaysia but there is no parallel development of standards and methods.  Therefore, there is a provision for education and training in the policy that will ensured the knowledge, qualifications and training of T&CM providers are adequate and also by using training program such as CPD/CME to ensure that T&CM providers and allopathic practitioners understand and appreciate the complementarities of the type of health care they offer.

For practices component of the policy, it incorporates the need of registrations of all traditional and complementary medicine .This includes the registration of type of therapies and their premises. It also states the need of guidance on regulatory and quality assurance standards, in form of guidelines to all traditional and complementary medicine practitioners. This is to ensure the safety, efficacy and quality of traditional and complementary medicine services.

Malaysia is rich with tropical biodiversity resources. It has been the reservoir for the major producer of traditional and complementary healthcare product. These practices, if not controlled, may lead to the extinction of endangered species and the destruction of natural habitats and resources. Therefore, several steps have been taken to ensure that our natural resources are protected and developed accordingly. In this component, it touches the need of provision of regular updating and expansion of the current monograph on Malaysian plants towards the production of pharmacopoeia for traditional and complementary products.

Traditionally, knowledge of the curative effect of certain plants has been handed drown from one generation to another by word of mouth. In case of illness, medicinal plants were applied for immediate treatment and in many cases were found to be effective. Unsurprisingly, research into medicine plants has been inadequate, resulting in paucity of data and inadequate development of methodology. One of the component in the policy, address the need of continuous research and documentation on active ingredients extracted from certain plants grown. The standardization of the medicinal plants for traditional medicine and experimental studies to determine the therapeutic effects of those plants need to be done. In the policy, intellectual property issues were address and protection of research discoveries on T&CM shall be developed and implemented.

The Division of Herbal Development under Ministry of Agriculture and Agro-based Industry has been upgraded from the herb development secretariat on 15 October 2014. It was highlighted under the National Agro-Food Policy (NAFP) and National Key Economic Area (NKEA) that Malaysia will produce and develop high quality herbal products. In order to produce high quality of herbs, the Ministry established the Cluster Development Areas and Permanent Food Production Park (TKPM) especially for herbs and spices in the East Coast Economic Regions (ECER) including Lembaga Kemajuan Kelantan Selatan (KESEDAR) or the South Kelantan Development Authority and Lembaga Kemajuan Terengganu Tengah (KETENGAH) or the Central Terengganu Development Authority. 

 

MALAYSIAN NATIONAL MEDICINES POLICY (MNMP)

INTRODUCTION 

The Malaysian Ministry of Health has introduced and carried out various policies related to medicine which aims to improve the health and well-being of the people. The Malaysian National Medical Policy (MNNP) which was published in year 2007 is an official document which combines the existing and future policies together, and showcases the medium and long-term strategies for the country’s pharmaceutical sector. The policy focuses on promoting equitable access to, and rational use of safe, effective, affordable and good quality essential drugs to improve the health outcome of the people. This policy relies heavily on the coordinated effort from the public and private sectors. 

In this Policy, traditional medicine is defined as “any product used in the practice of indigenous medicine, the drug consist of solely one or more naturally occurring substance of plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and homeopathic medicine (Control of Drugs and Cosmetic Regulations 1984).” 

The MNMP comprises of 4 core components and 4 supportive components:

1. QUALITY, SAFETY AND EFFICACY OF DRUGS

Policy: Only safe, efficacious and quality drugs that meet approved standards and specifications shall be registered and made available for sale and use in Malaysia.

Only quality drugs which meet approved standards and specifications for its safety, and efficacy shall be registered and made available for sale and use in Malaysia. Drug legislation and regulations which are already in place shall be strengthened and effectively enforced to ensure proper practices are observed in the development, production, importation, supply, marketing, sale and management of drugs.

The Drug Control Authority (DCA) which was established under the Control of Drugs and Cosmetics Regulations 1984 is responsible for pharmaceutical regulatory control in Malaysia. All medicines must be registered with the DCA. However, the registration of traditional medicines will be based on safety and quality, until such time when research in traditional medicines has developed to a stage where efficacy can be included as one of the prerequisites for registration. 

The National Pharmaceutical Control Bureau (NPCB) acts as the secretariat to DCA and is the agency that develops and implements the regulations relating to quality, safety and efficacy of drugs. 

Only manufacturers, importers and wholesaler that have been issued with licenses shall be permitted to handle registered pharmaceutical products. All related activities must adhere to Good Manufacturing Practice (GMP), Good Storage Practice (GSP) and other additional requirements as stipulated by the law. All licenses shall need to be reviewed and renewed according to the provisions of the law.

Only registered medical and dental practitioners can prescribe prescription drugs. Pharmaceutical enforcement officers shall examine every healthcare facility in relation to medicines. Advertisement and promotion of medicines including traditional medicine shall be regulated by the Ministry of Health. Patented drugs and drugs with Trade Marks shall have the protection conferred under the patent law and Trade Mark Law of the country. The flexibility of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement can be applied for the public health interest of the country.

An effective pharmaceutical quality assurance shall be in place involving all parties in the supply chain to ensure that all medicines are safe, effective, of good quality and meet all specifications and standards at every stage of supply throughout their shelf life before reaching the consumers. There will also be an on-going effective post marketing post-surveillance system including the monitoring of drugs with adverse effect.

2.  DRUG AVAILABILITY

Policy: An efficient and integrated drug management and supply network shall be maintained. 

Based on essential drugs concept, disease pattern, cost-effectiveness and therapeutic advantage are important criteria in the selection of medicines. In view of this, Essential Drugs Programme shall be developed which include the promotion of National Essential Drugs List (NEDL) and the establishment of evidence-based Standard Treatment Guidelines in harmony with the existing Good Clinical Practice (GCP). The selection of medicines will be the responsibility of the NEDL technical committee which is comprise of experts in medicine, pharmacy, dentistry, pharmacology, public health, consumer affairs, health economics and others as appointed by the Ministry of Health. 

The Ministry of Health shall set up a technical committee comprising of health and traditional practitioners and other experts from related fields. This committee shall establish the criteria for selection of traditional medicines based on WHO existing guidelines.

Essential drugs available to the population shall be of quality, safe, and effective. There should also be fair distribution, regular and adequate supply and available at affordable prices. Through appropriate planning, regular audit and close monitoring of the suppliers, the drug procurement system will be more effective. The policy aims for self-reliance through a shift from importation to increased local production, and in view of this priority shall be given to domestically manufactured medicines and incentives to eligible domestic manufacturers who have fulfilled certain criteria imposed by the government

3. DRUG AFFORDABILITY

Policy: The pharmaceutical industry shall be organized and regulated to create incentives and foster competition in drug prices. Appropriate financing mechanisms shall be developed to ensure essential drugs needed for quality healthcare are affordable.

Cost-containment measures shall be implemented through development of suitable and reliable financing mechanisms to ensure that the populations have easy access to essential drugs. Information on price trends of essential drugs shall be monitored with early detection of any price increase and other market condition. This is to enable prompt action to be taken to control sudden increase in the price of drugs. Drugs shall continue to be exempted from taxes and import duties in order that their    price shall remain at the lowest possible level.

 A rational pricing system shall be developed to ensure the stability of the price of drugs especially essential drugs. A database that monitors the cost of essential drugs in Malaysia shall be maintained in order to make comparisons with other countries. The price of all drugs shall be displayed clearly to ensure transparency and healthy competition in the market. 

Acquiring products from various sources by generic names shall be encouraged to stimulate healthy competition in medicine pricing. All dispensed drugs shall need to be labeled with generic (INN) medicine name either with or without brand name.

4. QUALITY USE OF DRUGS

Policy: Quality use of drugs by healthcare providers and consumers shall be promoted. Activities of the government, industry and media in support of informed and appropriate use of drugs by consumers shall be encouraged.

All healthcare providers who prescribe and dispense drugs shall possess the relevant minimum qualifications and well-trained. Pharmacists will play a more vital role not only in dispensing drugs but also will be expected to counsel patients on the drug usage.

The Ministry of Health shall educate the general public on the benefits and risks of drugs in collaboration with other relevant ministries, agencies including the mass media. Accurate, unbiased and relevant information on drug shall be widely    circulated to all healthcare providers, patients and the general public. Networking between all drug information centers shall be established for the purpose of sharing of information and resources including monitoring drugs with adverse reactions.    Product information leaflets and labeling of drugs shall be regulated to ensure the information given to the public is adequate simple, accurate and unbiased.

The national and hospital drugs and therapeutic committees shall coordinate and be responsible for the development of the National Essential Drugs List as well as the Standard Treatment Guidelines for in-house use.

The promotions, advertisements, and related activities on drugs must be carried out ethically and in accordance to the related law. The information given must be useful, reliable, accurate and up-to-date.

5. HUMAN RESOURCES DEVELOPMENT

Policy: The human resource needs of the pharmaceutical sector shall be planned and developed.

Proper and effective short and long-term manpower planning and training shall be implemented in order to ensure that there will be sufficient experts, professionals and trained personnel in the pharmaceutical sector. To maintain the quality of professionals that are being produced, accreditation of relevant programs offered by institution of higher learning or training centers shall be established. Training shall include on-the–job training, continuing education programmes, distance learning and other innovative training approaches such as virtual campus within the institutions shall be fully utilized.

6. RESEARCH AND DEVELOPMENT

Policy: Research in utilization, management and development of medicines shall be enhanced.

Greater emphasis shall be given to research for identification of the best approach for managing the drug delivery system and pharmaceutical care.

Basic and industrial research and development for safe, effective and efficacious drugs, including traditional medicines, shall be encouraged. This is for the purpose of reducing the effect of common diseases as well as new emerging and re-emerging health problems.

All of these research and development activities shall be achieved through cooperation between policy makers, healthcare providers, industry, academia, research institutions, professional body, non-governmental bodies (NGOs) and consumer associations. 

  7. TECHNICAL CO-OPERATION 

Policy: Technical collaboration and co-operation in the implementation and strengthening of relevant areas in the pharmaceutical sector shall be established with various stakeholders at the national, regional and international levels. 

The MNMP aims at encouraging technical co-operations to promote and explore best practices and agreed standards to optimize the utilization of existing available   resources. This shall be achieved through activities such as training, information sharing, expertise facilities, and harmonization of the legislation, regulations and guidelines related to medicines at national regional and international level.  

The Ministry of Health, shall on national level, be the main facilitator in coordinating activities between inter- and intra-agency, including sharing of information   between public and private sectors for the pharmaceutical service planning and implementation.  On international level, there will be close cooperation and liaison with   relevant international organizations, such as, Association of South East Asian Nations (ASEAN), World Health Organization (WHO), International Conference on Harmonization (ICH) and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

8. MANAGEMENT OF THE NATIONAL MEDICINES POLICY

Policy: All stakeholders shall be committed to the successful implementation of the National Medicines Policy.

A six-year master action plan shall be developed by the Government in collaboration with relevant bodies to facilitate the implementation of the MNMP. Functional capabilities to monitor, and evaluate the progress and impact of the MNMP shall be established.

All data for indicators which are recommended by the World Health Organization (WHO) shall be gathered and formed as part of National Healthcare Information System for pharmaceutical sector reference.

The progress of the implementation of the National Medicines Policy shall be monitored every 3 years and a full of evaluation will be done every 6 years. The result of the evaluation shall be made known to the public.[1]

Reference:

  1. Ministry of Health Malaysia, National Medicine Policy of Malaysia. 2007. Last accessed on 7 November 2012 and available online athttp://www.pharmacy.gov.my/aeimages//File/MNMP_DUNAS.pdf

Malaysia National Traditional and Complementary Medicine Policy

In the year 2001, the Malaysian Government established the National Traditional and Complementary Medicine (T&CM) Policy. The implementing agency in Malaysia is the T&CM Division, under the Ministry of Health Malaysia. The Policy stated that the T&CM system is an important component of the healthcare system.  It co-exists with modern medicine and contributes towards enhancing the health and quality of life of all Malaysians. The government will facilitate the development of T&CM in the country and ensures the quality, safe practices and products of T&CM.  It will support the identification of its health, economic and social benefits. Its vision is for T&CM to be optimally integrated into the Malaysian healthcare system to achieve a holistic approach towards enhancing health and the quality of life. Its main mission is to ensure quality and safe use of T&CM products and practices in order to attain the optimum potential in healthcare delivery through:

  • Promotion of the proper practice of T&CM particularly in the Primary Health Care delivery system
  • Appropriate education and training of T&CM practitioners
  • Adherence to acceptable standards of safety and quality for products and practices
  • Establishment of strong research and development activities in T&CM
  • Promotion and advocacy of T&CM
  • Conservation of plants and animals for progress of T&CM development
  • Enhancing international technical co-operation and exchanges relevant to T&CM

Contact Details

Traditional & Complementary Division
Ministry of Health Malaysia, Cenderasari Road
50590 Kuala Lumpur, Malaysia
Tel: +603 2698 5077/2279 8100
Fax: +603 2691 1259
Website: http://tcm.moh.gov.my


Reference:

  1. Traditional & Complementary Medicine Division, Ministry of Health Malaysia. National Policy of Traditional and Complementary Medicine. 2nd Edition, 2007. Last accessed on 26 November 2012 and available online at http://tcm.moh.gov.my/v4/pdf/NationalPolicy.pdf.

Malaysia National Policy on the Environment

  • General Information

In the year  2002, the National Policy on the Environment (NPE) was formulated and approved by the Department of Environment, which is under the Ministry of Natural Resources and Environment of Malaysia, which was previously under the Ministry of Science, Technology and Environment of Malaysia [1]. The NPE aims to promote environmentally sound and sustainable development in managing and conserving the environment, for the continuation of economic, social and cultural progress of Malaysia and enhancement of the quality of life of its people [1] [2]. As it moves towards the status of a developed country by the year 2020, Malaysia envisages their land should remain productive and fertile, and still rich in natural diversity.

Three main objectives of the Policy are:

  • A clean, safe, healthy and productive environment for present and future generations
  • Conservation of the country’s unique and diverse cultural and natural heritage with effective participation by all sectors of society
  • Sustainable lifestyles and patterns of consumption and production.[1]

This policy was based on the eight inter-related and mutually supporting principles that harmonised economic development goals with environment imperatives. These principles are:

  • Stewardship of the environment
  • Conservation of the nature’s vitality and diversity
  • Continuous improvement in the quality of the environment
  • Sustainable use of natural resources
  • Integrated decision-making
  • Role of the private sector
  • Commitment and accountability
  • Active participate in the international community [1]

This policy also seeks to integrate environmental considerations into development activities and in all related decision-making processes. A broad-based strategic approach is adopted to promote environmental soundness. Among the seven Green Strategies provisioned under this policy, there is one relevant to Traditional & Complementary Medicine:

  • Strategy No. 2 Effective Management of Natural Resources and the Environment
  1. A national inventory and audit of environment and natural resources will be maintained and regularly updated, with particular emphasis on depletion and renew ability, to serve as a guide to policy formulation and decision-making. Appropriate environmental monitoring systems shall be established to facilitate the evaluation of programmes and projects.
  2. Natural resource areas, particularly those containing biologically rich habitats and ecosystems will be established and maintained as zones for the conservation and protection of indigenous flora and fauna and genetic resources.
  3. The nation’s forests and their resources will be managed sustainably to ensure continued and sustainable economic benefits and compatibility with environmental stability, ecological balance and social stability of communities inhabiting such areas [1][3].

Significantly, this policy emphasises the integration of environmental dimensions in the planning and implementation with conservation of the natural diversity. It is to ensure the biodiversity and life support systems are integrated and accountable by all decision-makers in the public and private sectors, resource users, non-governmental organisations and the general public through efforts in sustaining the natural resources and preventing depletion of the environment [1][3]. Therefore, the NPE serves as an important framework as to ensure Malaysia participates actively and effectively in regional and global efforts towards environment conservation and enhancement.

Contact Details

Department of Environment
Ministry of Natural Resources and Environment
Level 1 – 4, Podium 2 & 3,
Wisma Sumber Asli No.25, 
Persiaran Perdana, Precint 4
Federal Government Administrative Centre
62574 Putrajaya,
Malaysia.
Tel: +603-8871 2000/2200
Fax: +603-8888 9987/ +603-8889 1040
Website: http://www.doe.gov.my


References:

  1. Department of Environment, Ministry of Natural Resources and Environment, Malaysia. Malaysia National Policy on the Environment. 2002. Last accessed on 18 Jan 2013http://www.doe.gov.my/portal/wp-content/uploads/2010/07/dasar_alam_sekitar_negara.pdf
  2. Ministry of Natural Resources and Environment. Report on National Capacity Needs Self-Assessment for Global Environmental Management and National Capacity Action Plan. 2008. Last accessed on 18 Jan 2013http://www.thegef.org/gef/sites/thegef.org/files/documents/document/ncsa-malaysia-fr-ap.pdf
  3. Malaysian Investment Development Authority (MIDA). Environmental Management. Updated 2012. Last accessed on 21 Janhttp://www.mida.gov.my/env3/index.php?page=policy

Health Policy Development in Ministry of Health Malaysia (MOH)

What Is Health Policy?

A health policy as defined by the World Health Organization (WHO) is a set of decisions to pursue courses of action aimed at achieving defined goals for improving the health situation. It forms the basis of health strategies, which lay the principal lines of action required for all stakeholders in health. Policies can be understood as political, management, financial and administrative mechanisms arranged to reach explicit goals. Health policy can in the form of written official government policy (legislative, guidelines that govern how laws and plan are put into action, plan document), verbal instruction of policy makers, broad ideas and goals of policy makers in manifestos and pamphlets, expressed explicitly or just as implied statements. There are different levels of policies such as national health policy, programme policy, state health department policy, hospital policy and departmental policy. The National Health Policy for Malaysia [1] has been developed which indicates the types and general magnitude of health sector changes expected in the next 15 years up to 2020, the values that guide the policy, the future health service delivery and the role of stakeholders in health.

Development of Health Policy In MOH

In politology the policy cycle is the "life' of how a policy is created and ended. It includes the following stages: agenda setting, policy formation, decision-making, policy implementation and policy evaluation (continue or terminate). Polices are dynamic, not just static list of goals and plans.

Health policy development in Malaysia has improved over the years. This is evidenced by the evolving process in the development of the 5-year rolling health plan. The process of formulation of the early Malaysia health plans was based on intuitive and experience of the top level policy makers. Since the 4th Malaysia Plan (1972) health policy was formulated based on the mixed of rational planning and intuitive planning processes. Health policy planning in Malaysia is in line with the global movement towards evidence-based policy development. Realizing the importance of local evidence and research needs Malaysia established the Institute of Medical Research (1900), which helps Malaysia as well as the Region in providing new knowledge in medical research and evidence of best practices particularly in managing the communicable diseases. The Health Management Information System (HMIS) was established in Malaysia to assist in development of policy and health planning. Other research institutes gradually emerged including the Institute of Public Health, Institute of Health System Research, Institute of Health Management, Clinical Research, Institute of Health Promotion and the recent one, the Institute of Natural Products, Biologicals and Vaccines. All these institutes are coordinated under the umbrella of National Institutes of Health, Malaysia. The Health Technology Assessment Unit and Evidence-based Unit are also established with the intention of providing reliable evidence for decision makings.

The need for evidence was articulated by policy makers to researchers at the research priority dialogue for example the MOH commission, the National Burden of disease Study and the evaluation of the 8th Malaysia Plan for the planning of the 9th Malaysia Plan. The evidence were analysed and interpreted based on local Malaysian context. In this case the policy makers showed their trust to the evidence, as it come from credible source and the result of these studies were referred to in the planning process.

Within limited data environment, the process of broad policy development for example in the development of the 5-year health plan: the 9th Malaysia Health Plan, MOH follows the best mix of rational planning and intuitive planning approach. The steps are described below:

  • Situational Analysis (Environmental scanning) – the analysis of situation based on available data and information on the health status of the population, the main health problems, the available resources (facilities, manpower, financial, technologies) and services. Each State Health Department documents its State Health Situational Analysis. Similarly, each Programme in the Ministry of Health (Medical, Public Health, Research and Technical Support and Management Programme) document it Programme Analysis include it achievements, shortfalls and prospects. Mid-Term Review of the previous Plan and Evaluation of the 5-year plan is carried out to provide input to the national health situational analysis. At the national level the MOH and the health and health-related agencies prepare paper through Technical Working Groups in relation to cross cutting issues. In the recent 9th Malaysia Plan (2006-2010) planning process, health situational analysis was carried out deriving evidence based on the National Burden of Disease Study, the Second National Morbidity Survey, Health Management Information System Reports, reports from medical and health, research and technical support and management programmes as well as the results of the evaluation of the 8th Malaysia Plan. The national overriding policies including the National Outline Perspective Plan (2001-2010) a long term framework plan (Rangka Rancangan Jangka Panjang, the Vision 2020, privatization policy, Malaysia MSC, among others contain the outline of the country's long term strategic development plan were analysed and taken into consideration in the development of health policies so as to ensure that health policies are inline with national policies.
  • Identification of problems, contributing factors and setting of priorities – this was based on the magnitude and nature of health problems such as the burden of diseases and breadth of gaps of resources and services in facing the issue of inequity and access. For example the top eight diseases with the highest DALYs in the National Burden of Disease and inadequate as well as inequitable distribution of human resource and medical services are placed high priority health challenges in the 9th Malaysia Plan.
  • Identification of feasible options including the appropriate strategies, options of health actions. Gross analysis has been carried-out in terms of broad strategies. Little evidence to illustrate whether there is a systematic analysis in identifying the most effective strategies.
  • Development of consultative methods. The whole process of health policy development and health planning has been conducted through a series of consultative methods with "top-bottom" and "bottom-up" approach. Consultations with other stakeholders including the private sector, the universities and other health and health related agencies were conducted too. Health planning is an integral part of the whole nation development planning process, thus placing health as one of the top national or country political agenda. The highest level being the Cabinet, the National Development Planning Council chaired by the Prime Minister and the National Planning Committee at the central agency level. The health policies were discussed at the Technical Working Groups of health experts and representative for stakeholders in health, the MOH Policy and Planning Committee, the Five Year Plan Conference, and consultative meetings at state and district and hospital levels.
  • The Plan Implementation, Monitoring and Evaluation

The Health plan produced is tabled to the Cabinet with indication of development allocation for the 5 year plan period from the Government. Health plan are implemented and monitored by giving feedback of achievement monthly to the central government coordinating agency (Implementation Coordination Unit), at Mid-Term Reviews and evaluation at the end of 5-year implementation.

Conclusion

Health policy reveals the values and the strategic direction that drive the country health system towards achieving its vision or common goals. The national health policies can be the guiding strategies and functions of the various levels of health care delivery system. Health policy is a dynamic and will be reviewed when necessary. The process of development of health policy is also evolving towards evidence-based development.

Reference

  1. Malaysia National Health Policy, MOH first edition 2006

 

Malaysia National Forestry Policy 1978 (Revised 1993)

National Forestry Policy was introduced in 1978 to strengthen and uniformized the forest administration and management in Malaysia. The Policy was amended in 1993, in line with the resolutions made by UNCED Conference in Rio de Janeiro (1992), enhances the need for sustainable management of forest resources in the country [1] [2]. The revised National Forestry Policy 1978 plays an important part for the success of Vision 2020, and for the nation's aspiration in providing a better living quality for the future generation. The National Forestry Policy 1978 (Revised 1993) aims to conserve and manage the forest through sustainable management and maintain its important roles in the national economy and preservation of environmental stability [2].

Briefly, the National Forestry Policy aims to achieve the following objectives:

  1. Permanent Forest Estate: To set aside sufficient areas of land strategically located throughout the country as Protection Forest, Production Forest, Amenity Forest, and Research and Education Forest as Permanent Forest Estate.
  2. Forest Legislation: To ensure the preservation and sustainable management of forest resources through efficient forest law enforcement.
  3. Sustainable Forest  Management: To manage the forest in accordance with the principles of sustainable yield management in order to maximise social, economic and environmental benefits of the nation and its people.
  4. Forest Regeneration and Rehabilitation: To upgrade programme of forest development through regeneration and rehabilitation operations in accordance with appropriate silvicultural practices to achieve maximum productivity.
  5. Forest Harvesting: To promote efficient harvesting methods within the prescribed forest management and efficient harvesting plans for maximum economic benefits from all forms of forest produce.
  6. Forest Products and Industries: To attain a rational balance between the national industrial processing capacity and resource availability.
  7. Bumiputra Participation: To continue promoting Bumiputra participation in the field of wood-based industries parallel with the Government's National Development Policy.
  8. Forest Plantation: To establish and manage forest plantations of indigenous and exotic species to supplement timber supply from the natural forest and to promote active private sector investments in the establishment and development of forest plantations on private lands.
  9. Agro-forestry: To promote active involvement of local community in agro-forestry projects.
  10. Non-wood Forest Product: To increase non-wood forest products for local consumption and to meet the need of related industries through scientific and sustainable management practices.
  11. Forestry Research: To encourage and support public and private sectors involvement in promoting scientific research for the purpose of enhancing maximum benefits from the forest.
  12. Manpower Development and Training: To increase trained manpower to meet the requirement of the forestry and wood-based industries.
  13. Forestry Education and Extension: To promote forestry education at all levels and to undertake publicity and extension services in order to generate better understanding among the public on multiple values of forest.
  14. Conservation of Biological Diversity: To carry out appropriate programmes for the conservation of unique species of flora and fauna.
  15. Community Forestry, Recreation and Tourism: To encourage active involvement of local community in forestry development projects by developing community forestry programme and provide facilities for recreation and tourism.
  16. Special Scientific Values: To set aside specific areas for the purpose of forestry education and scientific studies.
  17. International Co-operation: To foster closer international communication and co-operation in order to achieve a better understanding in the management and development of tropical rain forests [2].

 

Contact Details

Forestry Department Peninsular Malaysia (Headquarters)
Ibu Pejabat Perhutanan Semenanjung Malaysia
Jalan Sultan Salahuddin
50660 Kuala Lumpur, Malaysia
Tel: +603-2616 4488
Fax: +603-2692 5657
Website: http://www.forestry.gov.my/index.php/en/home.html
Forest Research Institute Malaysia (FRIM)
52109 Kepong
Selangor Darul Ehsan, Malaysia
Tel: 603-6279 7000
Fax: +603-6273 1314
Website: http://www.frim.gov.my/


References:

  1. Ministry of Natural Resources and Environment (NRE). Core business NRE; forestry. Malaysia [updated 2012 Oct 24; cited 2012 Oct 24]. Available from: http://www.nre.gov.my/English/Forestry/Pages/Forestry.aspx
  2. Malaysian Timber Council (MTC). National forestry policy 1978 (revised 1993). Malaysia [updated 2008 Aug 16, cited 2012 Oct 24]. Available from: http://www.mtc.com.my/issues/

National Policy on Biological Diversity

  • General information

The matters pertaining to biodiversity involve many Ministries and agencies in Malaysia which has developed a number of sectoral policies and laws governing biodiversity. In Peninsular Malaysia, several polices and acts related to biodiversity included the National Forestry Policy, National Environment Policy, 3rd National Agriculture Policy, National Wetlands Policy, Forestry Act 1984, Wildlife Protection Act 1972, National Park Act 1980 and Fishery Act 1985 for the management of biodiversity. At a sectoral level, agencies have also identified priority areas, including developing policy for protection of plant genetic resources, inventorying poorly-known groups of biological organisms such as lower plants and insect diversity, increasing the number of Virgin Jungle Reserves and implementing the National Policy for Integrated Coastal Zones Management [1]. Due to the crucial role played by biodiversity towards the continued survival of Malaysian people, the National Policy on Biological Diversity (NPBD) was developed and officially launched in 1988 under the previous Ministry of Science, Technology and Environment [2][3]. Currently, the Ministry of Natural Resources and Environment (NRE) is formulating a federal legislation concerning biodiversity, taking into account the existing legal frameworks set forth by the states of  Sarawak  and Sabah which are Sabah Biodiversity Enactment 2000 and Sarawak Biodiversity Centre Ordinance 1997  respectively [1].

This NPBD aims to conserve Malaysia’s biological diversity and to ensure that its components are utilised in a sustainable manner for the continued progress and socio-economic development of the nation [2][4]. Therefore, NPBD provides the direction for the nation to implement efforts according to the following objectives: 

  • To optimise economic benefits from sustainable utilisation of the components of biological diversity
  • To ensure long-term food security for the nation
  • To maintain and improve environment stability for proper functioning of ecological systems
  • To ensure preservation of the unique biological heritage of the nation for the benefit of present and future generations
  • To enhance scientific and technological knowledge, and educational, social, cultural and aesthetic values of biological diversity
  • To emphasize biosafety considerations in the development and application of biotechnology [2] 

By the year 2020, the NRE targets to transform Malaysia into a world centre of excellence in conservation, research and utilisation of tropical biological diversity [2]

NPBD outlines a total of 15 strategies with 96 action plans for the effective management of biological diversity: 

Strategy I - Improve the Scientific Knowledge base
Strategy II - Enhance sustainable utilisation of the components of biological diversity
Strategy III - Develop a centre of excellence in industrial research in tropical biological diversity
Strategy IV - Strengthen the institutional framework for biological diversity management
Strategy V - Strengthen and integrate conservation programme
Strategy VI - Integrate biological diversity consideration into sectoral planning strategy
Strategy VII - Enhance skill, capacities and competence
Strategy VIII - Encourage private sector participation
Strategy IX - Review legislation to reflex biological diversity needs
Strategy X - Minimize impacts of human activities on biological diversity
Strategy XI - Develop policies, regulations, laws and capacity building on biosafety
Strategy XII - Enhance institutional and public awareness
Strategy XIII - Promote international cooperation and collaboration
Strategy XIV - Exchange of information
Strategy XV - Establishing funding mechanisms [2][3][4]

This NPCB encourages the optimum use of the components of biological diversity with increased efforts towards conservation programmes and ensures fair distribution of benefits to the nation and local communities. It is hope that Malaysia’s continuous effort in protecting, conserving and managing biology diversity would be recognized internationally, subsequently gains international cooperation and collaboration as well as access to and transfer of relevant technology. 

Together with the 10th Malaysia Plan, the National Green Technology Policy is also an important component to support matters pertaining to the management of sustainable biological diversity. The National Green Technology Policy defines Green Technology as “the developments and application of products, equipment and system used to conserve the natural environment and resources, which minimizes and reduces the negative impact of human activities” [5]. Because biological diversity forms the foundation of the vast array of ecosystem services, any effect on it will have an impact to the well-being of human as a whole, thus it is critical that the biological diversity be safeguarded and well-maintained for a sustainable future through concerted efforts driven by this policy.  

Contact Details 

Ministry of Natural Resources and Environment
Wisma Sumber Asli No.25,
Persiaran Perdana, Precint 4
Federal Government Administrative Centre
62574 Putrajaya, Malaysia.

Tel: +603-8886 1111

Fax: +603-8889 2672

Website: http://www.nre.gov.my

References:

  1. Convention on Biological Diversity. Malaysia - Overview. Convention since 1994. Last accessed on 22 Jan 2013 at http://www.cbd.int/countries/?country=my
  2. Ministry of Science, Technology and the Environment, Malaysia. National Policy on Biological Diversity. 1988. Last accessed on 22 Jan 2013 at http://www.cbd.int/doc/world/my/my-nbsap-01-en.pdf
  3. Akademik Sains Malaysia. Achievements, opportunities and challenges: Conference on Biodiversity and National Development. 2009. Last accessed on 22 Jan 2013 at      http://www.akademisains.gov.my/download/proceedings/Biodiversity.pdf
  4. Ministry of Natural Resources and Environment, Malaysia. Report on National Capacity Needs Self-Assessment for Global Environmental Management and National Capacity Action Plan. 2008. Last accessed on 22 Jan 2013 athttp://www.thegef.org/gef/sites/thegef.org/files/documents/document/ncsa-malaysia-fr-ap.pdf
  5. Ministry of Energy, Green Technology and Water, Malaysia. National Green Technology Policy. Last accessed on 28 Jan 2013 at http://portal.ppj.gov.my/c/document_library/get_file?p_l_id=17335&folderId=27605&name=DLFE-4709.pdf

Malaysia National Agro-Food Policy

Until year 2010, the development for agricultural and forestry was under the directive of the Third National Agricultural policy (NAP3). Subsequently, NAP3 focuses on enhancing food security, increasing the productivity and competitiveness, deepening linkages with other sectors, venturing into new frontier areas as well as conserving and utilizing natural resources on a sustainable basis [1].  However, because of the increase in food demands of a high-income population, it leads to an increase in the price of food. Consumers have higher expectations as they are more health-conscious and highly concerned about what and how the food is produced [2]. In addition, the development of high value-added natural resources products including the development of traditional and complementary medicines (T&CM) is still limited and the exports consist of primary and intermediate products only [1].  Changes in the local economy have brought forth new issues and challenges towards the agricultural sector which include acute labour shortage, limited availability of suitable land and increasing cost of production both in local and also the global market [1]. Hence, the agricultural sector requires becoming more innovative and efficient in managing their natural resources as to enhance the economic contributions and growth of the agricultural sector.

Therefore, the 10-year National Agro-Food Policy has been developed by the Ministry of Agriculture and Agro-based Industry Malaysia which was approved by the Malaysian Cabinet on 28 September 2011, to replace the NAP3 [3]. This policy covers the period between 2011 and 2020; and mainly addresses the issue of food supply in Malaysia based on consumer’s need for quality, safety, nutrition, functionality and environmental sustainability [3][4]. This policy also targets to make agro-food industry as a competitive and sustainable industry; and to increase agro-based entrepreneur’s level of income [5]. The abundance of crop diversity in Malaysia provides opportunity for the development of an improved nutrition and better health food products, which in turn provide more choices for the consumers especially towards the local products [4].

The aims of the policy follow the strategic directions as below:

  1. Ensure national food security
  2. Increase the contribution of agro-food industry
  3. Completing the value-chain
  4. Empowering human capital
  5. Creating the environment for private sectors-led business
  6. Strengthen the activities of R&D, innovation and the use of technology
  7. Strengthening the delivery system [4][5]

This policy encourages the exploration of the potentials of high value agricultural products such as herbs and spices for nutraceuticals, cosmeceuticals & phytomedicines applications, seaweeds for pharmaceuticals and biomaterials usage, and edible bird’s nests for high-value food and health supplements. The development of high value agriculture initiatives hopes to create the next generation of agribusiness entrepreneurs to tap into the vast business markets, and this transformation may attract more investments from local and global markets[5]. Subsequently, the income of agribusiness entrepreneurs will increase and the natural resources would be fully utilized.

Contact Details

Ministry of Agriculture & Agro-Based Industry Malaysia
Blok 4G1 Wisma Tani, No.28 Persiaran Perdana,
Presint 4, Pusat Pentadbiran Kerajaan Persekutuan,
62624 Putrajaya, 
Malaysia
Tel: +603-88701000
Fax: +603-88886906
Website: http://www.moa.gov.my


References:

  1. Third National Agricultural Policy (1998-2010). Last accessed on 22 Jan 2013http://pmr.penerangan.gov.my/index.php/maklumat-kenegaraan/260-third-national-agricultural-policy--1998-2010-.html
  2. Southeast Asian Council for Food Security & Fair Trade. Malaysia towards New National Agricultural Policy. Last accessed on 22 Jan 2013http://www.seacouncil.org/seacon/index.php?option=com_content&view=article&id=338:malaysia-towards-new-national-agriculture-policy&catid=52:food-security&Itemid=82
  3. MARDI. National agro-food policy. Last accessed on 22 Jan 2013http://www.mardi.gov.my/documents/10138/84337a74-8185-4ddb-b464-8f76e00bd858
  4. Akademi Sains Malaysia. Last accessed on 22 Jan 2013http://www.akademisains.gov.my/download/workshop/obesity/paper8.pdf
  5. Ministry of Agriculture & Agro-Based Industry Malaysia. Dasar Agromakanan Negara 2010-2020 (DAN). Last accessed on 22 Jan 2013http://www.moa.gov.my/web/guest/dasar-agromakanan-negara-2011-2020-dan

Biotechnology Policy in the Healthcare Sector

National Biotechnology Policy

Biotechnology is recognised globally as a rapidly emerging and far-reaching technology and Malaysia recognizes it as a new engine for economic growth of the country [1]. The technology is aptly described as the "technology of hope" for its capability in improving the quality of life by generating new wealth and income for both rural and urban populations thus improving the socio-economic status of the population as a whole [1]. The recent development of R&D in life sciences creates a promising future in the healthcare development.

Malaysia recognizes the potential of natural biotechnology and the need for country's resources to be deployed in a more structured and focused manner. With this view, a biotechnology policy was formulated focusing on measures to protect the national interest and to support the growth of biotechnology in the country. On the 28 April 2005, the policy was unveiled by the Prime Minister of Malaysia at the opening ceremony of the BioMalaysia 2005 conference at the Putrajaya. As the Malaysian government anticipated the need of a driving policy for the biotechnology to grow competitively in the region, the biotechnology policy was laid out with comprehensive action and implementation plans to guide the execution of the policy for the growth of the biotechnology sector. The Ministry of Science, Technology and Innovation Malaysia (MOSTI) has been the driving force for the natural products commercialization development. Even now, some of the researched products funded under the MOSTI are currently available in the market through the collaboration with the pharmaceutical players in the country. These show that government is committed towards the wealth creation and societal well-being as addressed in the 9th Malaysian Plan. International Convention Center

At the initial phase of biotechnology development, Malaysia is targeting to shift the biotech sub-sectors, such as, the agriculture, healthcare and manufacturing sectors to the high-tech stage. The Prime Minister outlined nine major initiatives to realize the country's potential in the biotechnology sector and two of the initiatives are closely linked to the natural products development [1]. They are:

Thrust No. 2

To capitalise on the strengths of biodiversity to commercialise discoveries in health-related natural products and bio-generic drugs.

Thrust No. 3

To leverage our strong manufacturing sector by increasing opportunities in bio-processing and bio-manufacturing.

These two thrusts reflect one of the main principles behind the national biotechnology policy - which is to leverage the country's existing capabilities and to move them up the value chain.

Focus on Natural Products and Products Development

The global healthcare market, which comprises of a large number of therapeutic biotech drugs and vaccines worth US$40 billion, proves the importance of biotechnology [2]. It has also proven to have benefited over a hundred million people worldwide. Hundreds more of such products are in clinical development.

Over the years, the fundamental research on herbs and medicinal plants funded under the MOSTI research grants mechanism remain focused on enhancing the capability of natural products. The research has been targeted to look for compounds that alter the activity of a particular disease.

Recently, an important element has been incorporated into the natural product research, especially those under the funding request at the Science Fund mechanism which is, through the use of rational drug design, genetic manipulation of targets and random screening. This has led to the downsizing of the use of natural products in drug discovery. The major advantage of natural products for random screening is the natural diversity provided by natural products.

In recognition of the latest development of Innovation Model by the Minister of Science, Technology and Innovation, the research & development sector has changed the approach mechanism. Market-driven innovation model is the driving factor for the development of product through R&D especially in the pharmaceutical area [3]. This model will assist in accelerating the pace of product development and the product will be ready for the market faster than the usual conventional way. Platform technologies can be acquired and apply to assist in the research and development process. A shorter duration for drug development can be expected with the new initiative.

Focus on Traditional Knowledge

Traditional knowledge on medicinal practice by the indigenous people and folks in the rural area has yet to be fully documented, standardized, regulated and protected. Their knowledge can be properly researched and understood as it may be useful in the cure development for localized disease. Due recognition are given to this group of people in many countries such as Thailand, countries in the African continent, China, Taiwan and others. In Malaysia, although regulations and protection of traditional medicine have yet to be established, the practice and usage are growing in popularity. There is an urgency to address the issue and also other issues which include internationally acceptable standards and quality of both the medicines and traditional practice, and issues on the excessive harvest of medicinal plants which posed as a threat to the biodiversity.

Focus on Building International Recognition

Thrust eight of the National Biotechnology Policy sets out to build international recognition for Malaysian biotechnology. Undeniable, biotechnology has become a globalised activity and Malaysia would not want to miss any part of the development. Countries from all over the globe are trying to find a niche within the global biotechnology value chain. Similarly, Malaysia needs to identify its niche areas and strengths to offer to the world. In fact, pharmaceutical and nutraceutical (derived from medicinal herbal) are some of the niche areas that Malaysia will focus on to develop its healthcare biotechnology.

Towards Biotechnology Policy Focusing on Healthcare

In Malaysia, efforts to develop or evaluate the existing and often imported health technologies are often faced with various constraints such as scientific uncertainties, concerns over intellectual property rights, high development costs of idiosyncratic product reaction, increased litigation cost due to alleged effects of new products, restricted market size, non-profitability resulting from pressures to reduce prices and embedded disincentives in entering Malaysian market.

Part of the challenge in the design of healthcare biotechnology policy lies in developing ways of encouraging the creation of new technologies and technologies acquisition as mentioned in the Innovation (Market-driven) Model, on the one hand, and exercising control over the diffusion and utilization of technology on the other.

The pursuit of these somewhat contradictory objectives requires a delicate balance between the national health needs that require the acquisition of technology, and the need for a rational development plan for the healthcare system based on the principles of optimizing the use of existing technologies in the country.

With the development of healthcare biotechnology in the country, there is a great opportunity for Malaysia to be among the major players in healthcare industry. With the government playing a very supportive role in adopting an acquisition strategy to accelerate development of technological capacity in the healthcare sector, Malaysia will experience a transformation process to an innovation-led economy especially in the area of biotechnology.

Reference:

  1. MOSTI, (2005). Biotechnology for Wealth Creation and Social Well-Being-The Way Forward.National Biotechnology Policy, Pg. 4.
  2. Biotechnology—a sustainable alternative for chemical industry, (2005). Biotechnology Advances, Vol. 23, Issues 7-8, Pp. 471-499.
  3. Malaysia National Innovation Model, (2007), launched by YAB Dato' Seri Abdullah bin Haji Ahmad Badawi, Prime Minister of Malaysia at the National Innovation Conference and Exhibition (NICE) 2007, (26 November 2007) .
  4. Speech by YAB Dato' Seri Abdullah bin Haji Ahmad Badawi, Prime Minister of Malaysia at the Launch of BioMalaysia 2005, (28 April 2005).

 

Laws & Regulations

Traditional and Complementary Medicine Act 2013 - Act 756

The safety and efficacy of traditional remedies and practices have become a cause of concern for both health authorities and the public [1] [2]. In view of this, the health care system in Malaysia has undergone some changes to bring Traditional & Complementary Medicine (T&CM) into the mainstream system while ensuring safety to the public [1].

The Traditional and Complementary Medicine Division (T&CMD), Ministry of Health, Malaysia is the regulatory body responsible for overseeing the practice of T&CM in Malaysia. The task of this division is to ensure that T&CM practice in Malaysia is safe and conforms to acceptable standards for the benefit of the public [3]. Currently there are six practice areas that are recognised in Malaysia namely traditional Malay medicine, traditional Chinese medicine, traditional Indian medicine, homeopathy, complementary therapies as well as Islamic medical practice [3][4].

In February 2013, the Traditional and Complementary Medicine Act (Act 756) was gazetted. When the Act is enforced, this legislation will provide a solid foundation for the regulation of T&CM practices, the foremost being the registration of practitioners [4][5]. In addition, this Act provides for the establishment of the Traditional and Complementary Medicine Council, which will serve as the highest authority regarding T&CM practice in Malaysia. The functions of this Council are as follow:

  1. to advise the Minister on matters of national policy relating to T&CM practice;
  2. to establish the eligibility requirements for each practice area;
  3. to recognise qualifications conferred by any institutions of higher learning established under any written law in Malaysia or any institutions of higher learning recognised and authorised by any countries outside Malaysia for the purpose of registration under this Act;
  4. to specify the appropriate academic qualifications or recognised skills certificate issued
  5. to specify the necessary apprenticeship and training required;
  6. to register individuals who will provide T&CM services to the public;
  7. to issue practising certificates to registered practitioners;
  8. to develop codes of professional conduct, rules relating to the professional conduct of registered practitioners;
  9. to develop, undertake, prescribe and mandate any matter relating to or connected with the practice of T&CM or the professionalism of such practice;
  10. to specify, provide for and administer a complaints procedure and process;
  11. to develop rules upon which registered practitioners are to refer their patients to medical practitioners or dental practitioners, as the case may be;
  12. to obtain such relevant information from practitioners, and to provide the same to the Minister;
  13. to carry out such functions as ay be specified by this Act; and
  14. to carry out all such other activities as may be directed by the Minister and such direction shall be consistent with the purposes of this Act [5].

The requirement of registration of T&CM practitioners is also emphasised in this Act. A person intending to practise T&CM in any recognised practice area shall apply to the Council to be provisionally registered as a practitioner. A provisionally registered practitioner shall undergo a period of residency of not less than one year with any hospital or institution in Malaysia which is approved by the Council to enable him to be registered as a practitioner. When he is registered, he shall make an application for a practising certificate in the prescribed form and pay the prescribed fee to the Registrar. The practising certificate shall be displayed at the registered practitioner’s place of practice. Any person who commits an offence under this Act shall be liable to a fine not exceeding RM30, 000 (thirty thousand ringgit) or imprisonment for a term not exceeding two years or both, in respect of a first offence. The person may not apply to be registered until the expiry of a period of two years from the date of conviction [5]. As set forth in the Act, the obligations and duties of registered practitioners are summarised as below:

  1. use of titles and abbreviations;
  2. duty to refer patient to medical or dental practitioner;
  3. duty to report any epidemic or other localised outbreaks of diseases etc., to the Registrar;
  4. use of medical device;
  5. advertisement and promotion;
  6. registered practitioners may incorporate his practice into a company with limited liability, practice as a company or enter into a partnership
  7. mandatory practice standards in governance and practice codes [5][6].

Thus, it is hoped that T&CM will become a regulated profession and continue to develop within a safe and controlled environment to ensure public safety. The establishment of this Act creates public confidence by allowing them to check on the practitioner's registration status, and encourages practitioners to upgrade their knowledge and skills as necessary. 

 

Contact Details

Traditional & Complementary Medicine Division
Ministry of Health Malaysia, Jalan Cenderasari,
50590 Kuala Lumpur, Malaysia

Tel: +603 2698 5077/ 2279 8100

Fax: +603 2691 1259

Website: http://tcm.moh.gov.my

 

 References:

  1. Traditional and Complementary Medicine Division, Ministry of Health: A handbook of traditional and complementary medicine programme in Malaysia. Kuala Lumpur (Malaysia): Ministry of Health Malaysia; 2011
  2. World Health Organization. National Policy on Traditional Medicine and Regulation of Herbal Medicines: Report of WHO Global Survey. Geneva: World Health Organization; 2005.
  3. Traditional and Complementary Medicine Division, Ministry of Health Malaysia. Last accessed on 9 January 2013 athttp://tcm.moh.gov.my/v4/
  4. Bernama. Integrating Siddha medicine in Malaysian primary healthcare. New Strait Times.2013 November 28; Sect. Latest news. Last accessed on 28 November 2013 at http://www.nst.com.my/latest/intergrating-siddha-medicine-in-malaysian-primary-healthcare-1.415065#ixzz2mHODmasy
  5. Laws of Malaysia. Traditional and Complementary Medicine Act 2013 (Act 756). Last accessed on 26 November 2013 athttp://www.lawnet.com.my/lawnetpublic/Members/tabid/53/ctl/SubDocumentDetails/mid/369/Default.aspx?DocumentID=76832
  6. Puvanandran D. Taklimat Akta Perubatan Tradisional dan Komplementari 2013 (Akta 756). Presented at: Jerayawara (Roadshow) Perubatan Tradisional dan Komplementari. Traditional and Complementary Medicine Division, Ministry of Health Malaysia; 2013. Last accessed on 8 January 2013 at http://tcm.moh.gov.my/v4/bmelayu/modules/mastop_publish/?tac=120

 

Standards & Guidelines

In Malaysia, standards and guidelines pertaining to Traditional and Complementary Medicine (T&CM) has always been one of the top priorities that every T&CM stakeholders must take into consideration when involving with the T&CM sector. Several ministries and government agencies such as Ministry of Health (MOH), Ministry of Environment (MOE), Ministry of Science, Technology and Innovation (MOSTI), the states governments and many more research institutions and private sectors involvement are crucial to the development and establishment of several standards and guidelines that are related to TM/CAM in Malaysia.

T&CM Products

In order to be at par with T&CM products produced from developed nations, starting from the collection of raw materials such as plants, plants processing and storage, Research & Development (R&D), drug registration which include traditional medicine, herbal-based products and botanicals, manufacturing process until marketing and post-surveillance, even importation and exportation of related products need to be conformed to related standards and guidelines, which are developed, adopted and adapted from existing international benchmarks. [1]

The Economic Transformation Programme (ETP) is a comprehensive effort that will transform Malaysia into a high-income nation by 2020.[2] To kickstart ETP, both private and public sector have identified 12 National Key Economic Area (NKEA). One of the Entry Point Projects (EPP) 1 is aimed at unlocking the value of Malaysia’s biodiversity through herbal products. This EPP main focuses are:

  • Product development of nutraceuticals and botanical drugs based on 5 selected herbs - Tongkat Ali, Kacip Fatimah, Misai Kucing, Hempedu Bumi, Dukung Anak.
  • Upstream supporting initiative of Herbal Cultivation Park for commercial production of raw materials.
  • 5 R&D Clusters of Excellence formed to co-ordinate the R&D for each research institution (RI) and research universities (RU) in respective clusters: Discovery, Crop Production & Agronomy, Toxicology/Pre-clinical, Product Development & Processing Technology
  • Establishment of Herbal Development Council to oversee the development of the industry. [3]

T&CM Practices

In terms of T&CM practices, the current policy supports the co-existence of T&CM with modern medicine and its contribution towards enhancing the health and quality of life of all Malaysians.  To ensure the quality and safe use of T&CM practices, strong emphasis has been given on adherence to acceptable standards of safety and quality of practices. [1]

Malaysia has taken positive and proactive approach towards integrating safe and quality ensured T&CM practices into the national health systems. [1] Several integrated hospitals in Malaysia have established respective T&CM Units which provide T&CM services such as Acupuncture, Malay Massage, Herbal Therapy as Adjunct Treatment for Cancer Patients and Malay Postnatal Treatment. Malaysia has developed several guidelines on these practices in order to promote the highest standards in the practices and also to ensure public safety.[4]

References

  1. Traditional and Complementary Division, Ministry of Health Malaysia. National Policy on Traditional and Complementary Medicine, 2002. Last accessed on 12 November 2012 at http://tcm.moh.gov.my/v4/pdf/NationalPolicy.pdf
  2. Overview of Economic Transformation Programme. Last accessed on 12 November 2012 at //etp.pemandu.gov.my/Overview-@-Overview_of_ETP.aspx%20">http://etp.pemandu.gov.my/Overview-@-Overview_of_ETP.aspx
  3. Economic Transformation Programme: Agriculture. Last accessed on 12 November 2012 at //etp.pemandu.gov.my/Agriculture-@-Agriculture_.aspx">http://etp.pemandu.gov.my/Agriculture-@-Agriculture_.aspx
  4. Traditional and Complementary Division, Ministry of Health Malaysia. Practice Guidelines. Last accessed on 12 November 2012 athttp://tcm.moh.gov.my/v4/modules/mastop_publish/?tac=50.

Guideline for the Conduct of Bioavailability and Bioequivalence Studies

The guideline was published in the year of 2000 with based on similar contents from “Note For Guidance On The Investigation of Bioavailability And Bioequivalence “, which is  a standard set of guidelines outlined especially for The European Agency for the Evaluation of Medicinal Products (EMEA). However, some adaptation has been made for Malaysian application.

The objective of the guideline is to define products with systemic effect where bioavailability (BA) and bioequivalence (BE) studies are necessary and to formulate requirements for their design, conduct and evaluation. It serves as guide to the local researchers in conducting Bioavailability and Bioequivalence Studies (BA/BE) in accordance to established international ethical guidelines and scientific standards.

The guideline also provides detailed definitions on the terms such as pharmaceutical equivalence, pharmaceutical alternatives, bioavailability, bioequivalence, essentially similar products and therapeutic equivalence. The core topics in the guideline relate to design and how studies are to be conducted. It also highlights the necessity to submit BA/BE studies for new and approved active substances.

A standard format of BA/BE study report is also available  in the guideline.[1]

Any enquiries please refer to National Pharmaceutical Control Bureau.

Reference

  1. National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Malaysian Guidelines for the Conduct of Bioavailability and Bioequivalence Studies, 2000. Last accessed on 12 November 2012 at http://portal.bpfk.gov.my/index.cfm?&menuid=122.

Guidelines of Stability Studies of Drug Products

The objective of the guideline is to assist the pharmaceutical industry in conducting stability studies and/or in the submission of stability data in a form that is acceptable to the Drug Control Authority (DCA), Ministry of Health Malaysia. It is also formulated for the purpose of ensuring consistency and quality of the stability data submitted to the DCA for meaningful determination of shelf life of the products.

The guideline applies to products for human consumption or use only and do not apply to veterinary products, diagnostic agents and test kits for laboratory use, non-medicated medical and contraceptive devices and non-medicated bandages, surgical dressings, plasters and dental fillings.

The main element of the guideline is the proposed study design which covers topics on test samples and test conditions. It also highlights topics on analytical test methods, shelf-life prediction, additional stability data, format on stability report and information required pertaining to stability studies to be submitted for product registration.  

The guideline was prepared using references from WHO, Australian Drug Registration Guidelines and ICH Harmonised Tripartite Guideline and in certain cases whole sections of these references have been extracted and adapted.[1]

 Any enquiries please refer to National Pharmaceutical Control Bureau.

Reference

  1. National Pharmaceutical Control Bureau, Ministry of Health Malaysia: Guidelines for Stability Studies of Drug Products, 2000. Last accessed on 12 November 2012 at http://portal.bpfk.gov.my/index.cfm?&menuid=122.

Drug Registration Guidance Document

This document serves as the reference guide for applicants to register both pharmaceutical and traditional products for human use.

This document outlined several guidelines, which have been developed based on the legal requirements, primarily that of the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984. Every effort has also been made, wherever possible, to include the requirements of other related legislation, namely:-

  1. Dangerous Drugs Act 1952;
  2. Poisons Act 1952;
  3. Medicine (Advertisement & Sale) Act 1956;
  4. Patent Act 1983; and also
  5. Any other relevant Acts.

Applicants must be aware that it is still their responsibilities to ensure that their products duly comply with the requirements of the above legislations.


The guideline consists of two sections:


Section 1 - General Overview of the Drug Registration System in Malaysia (Including Administrative Procedures)

  • Gives updated information relating to administrative requirements and procedures.
  • Current information on Drug Control Authority (DCA) policies.


Section 2 – Guide on How to complete The On-Line Application Form For A New Product Registration

  • Outlines the on-line application process and requirements which will incorporate the ASEAN technical requirements and standards for pharmaceuticals (where applicable).[1]

There is an amendment done in October 2012 on this document.


Note : * A review of policy matters is an on-going process and  will continue, taking into account the global regulatory environment, to allow for timely and pertinent changes.

Any enquiries please refer to National Pharmaceutical Control Bureau.

Reference

  1. National Pharmaceutical Control Bureau, Ministry of Health Malaysia. Drug Registration Guidance Document. Last accessed on 27 November 2012 at http://portal.bpfk.gov.my/aeimages//File/RGDOC_updated_Oct_2012_edited_121112.pdf.

Guidelines for Applications of Clinical Trial Import License and Clinical Trial Exemption

This guideline serves as a reference for Applicants of Clinical Trial Import License/Permit (CTIL) which authorizes for the import any unregistered product and for Clinical Trial Exemption (CTX) which permits the manufacture of unregistered local product.  In both instances, the authority is given for the purpose of clinical trial only.

CTIL is required before an unregistered product can be brought into Malaysia, and Clinical Trial Exemptions (CTXs) is issued as permission to manufacture unregistered products in Malaysia, both for clinical trial use.

The guideline is prepared in line with the legal requirements imposed by the Control of Drugs and Cosmetics Regulations 1984, and The Poisons Regulation (Psychotropic Substances) 1989 involving controlled substances.

Section I of this handbook lists out the products that require CTIL and CTXs, Application formalities for CTIL and CTXs, and Details in processing the application and conditions for CTIL and CTXs.

Section II recommended formats as in Annex A (Clinical Trial Protocol), B (Pharmaceutical Data) and C (Investigator’s Brochure) are provided for the convenience of the Applicants. [1]

Enquiries on Clinical Trial Import License/Permit and Clinical Trial Exemption, application forms and application guidelines can be downloaded from the NPCB website.

Any enquiries please refer to National Pharmaceutical Control Bureau.

Reference


1. National Pharmaceutical Control Bureau, Ministry of Health Malaysia. Guidelines for Application of Clinical Trial Import License and Clinical Trial Exemption in Malaysia. Last accessed on 12 November 2012 at http://portal.bpfk.gov.my/index.cfm?&menuid=122

Guidelines on Good Manufacturing Practice (GMP) for Traditional Medicines and Health Supplements (TMHS)-First Edition (2008) 

Good Manufacturing Practice (GMP) is a set of manufacturing guidelines designed to ensure that every batch of the products meets the specified quality standards. The establishment of GMP standards for the Traditional Medicines and Health Supplements (TMHS) industry will help to improve the quality of locally manufactured products and this will in turn increase the percentage of healthy population in Malaysia.

These Guidelines are dynamic tools in ensuring that high quality products are produced in line with the current standards. It is being regularly updated, for instance, when the previous Guidelines on Good Manufacturing Practice for Traditional Medicines (2003) were revised, references were made to internationally recognized documents like EU - Annex 7; Manufacture of Herbal Medicinal Products (Volume 4; EU Guidelines to Good Manufacturing Practice), and WHO - Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Herbal Medicines and CRN - Council for Responsible Nutrition; Guidelines for Good Manufacturing Practice for Manufacturers of Food Supplements.

The Guidelines were improvised further incorporating current requirements for Traditional Medicines and Health Supplements into a single set of guidelines, namely the GMP Guidelines for TMHS, in order to comply with stringent manufacturing requirements in line with the international standards.

The new GMP Guidelines for TMHS (2008) is acknowledged by the Pharmaceutical Inspection Corporation Scheme (PIC/S) as improved version in comparison to Annex 7 on herbal medicines of the PIC/S GMP Guide. The Guidelines have also been proposed as a working document during the GMP Workshop (22 – 24 May 2007 - Kuala Lumpur, Malaysia) to formulate the 1st Draft of the TMHS GMP Guidelines for ASEAN, for which Malaysia had been appointed as the Lead Country for GMP initiative under the Asean Consultative Committee for Standards and Quality for Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG).

The format and requirements of the new guidelines have been updated in which reference has been made to PIC/S Guide to GMP for Medicinal Products. The 14 Chapters of previous guide have been summarized into 9 chapters, namely Quality Management, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Contract Production and Testing, Distribution, Complaints and Product Recalls and Self Inspection.[1]

Kindly visit NPCB’s official website at http://www.bpfk.gov.my for further details.

Reference

1.   National Pharmaceutical Control Bureau, Ministry of Health Malaysia. Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements, 1st ed. 2009. Last accessed on 12 November 2012 at http://portal.bpfk.gov.my/index.cfm?&menuid=122

Handbook on Environmental Impact Assessment in Sabah (Second Edition)

1. Description:

This handbook is printed as a second edition which follows Environment Protection Enactment 2002 approval and the subsidiary legislation on 3rd of January 2006. Conservation of Environment Enactment 1996 was replaced by the Environment Protection Enactment 2002. This handbook is meant to guide project proponents and consultants in preparation of relevant reports in order to protect the environment in Sabah.

In Enactment 2002, the Prescribed Activities Order was reviewed and revised to allow two categories that require either a proposal for mitigation measures report (PMM) or an environmental impact assessment report (EIA).

PMM are a series of proposals which describe the environmental impacts because of development activities; the measures required to avoid and mitigate bad environmental impacts, or to protect the environment; and the monitoring programme required to ensure compliance with mitigation measures and/or to monitor waste impacts. The prescribed activities that need PMM report is usually of low magnitude in terms of region and sensitivity. The impacts are known or can be predicted even with no detailed assessment study, and the mitigation measures and monitoring mechanism are in place.

EIA report is defined as a report or a series of reports with detailed assessment in quantitative and qualitative terms of the likely environmental impacts of a development activity; the measures required to avoid and mitigate bad environmental impacts, or to protect the environment; and the monitoring programme required to ensure compliance with mitigation measures and/or to monitor waste impacts. The prescribed activities which are normally of high magnitude in terms of region and sensitivity, and thus require detailed assessment study to forecast the potential impacts and to formulate practical, realistic and effective mitigation measures and monitoring programme.

 

2. Content:

This handbook provides detailed and step by step guidelines in the preparation of the proposal for mitigation measures (PMM) and environmental impact assessment report (EIA).

PMM

There are 7 steps that are compulsory to be followed: project screening, selection of environmental consultants, preparation of scoping notes, undertaking of the proposal for the mitigation measures study, preparation of proposal for mitigation measures report, submission of proposal for mitigation measures report and the preparation of the mitigation declaration. Every step is described in detail in this handbook.

EIA

There are 8 steps that are compulsory to be followed: project screening, selection of environmental consultants, preparation of scoping note, preparation of terms of reference (TOR), and undertaking EIA study, preparation of the EIA report, submission of the EIA report and the preparation of the Agreement of Environmental conditions.  TOR describes a framework written for study that proposed to be continued in a manner that systematic. There are two types of EIA which known as Normal EIA and Special EIA. For Special EIA, a special review panel will be established to assist in the review of the TOR taking into account the public feedbacks. The public feedback can be done either to the Sabah’s EPD office or its’ homepage after an announcement in major local newspapers stating that the TOR or EIA Reports are available at EPD’s office and homepage, main branches of the state library, and the environmental consultant’s office.

This handbook includes four annexes which state the categories of prescribed activities requiring PMM and EIA in Annex 1. Annex 2 provides guidelines for the preparation of scoping note. Annex 3 determines the methodology of the assessment study and Annex 4 shows chapter by chapter recommendations for the content of PMM report and EIA report.

3. Specific Information:

There are several objectives of environmental impact assessment as follows:

  1. To examine and choose the most appropriate development options available whenever possible;
  2. To identify, forecast and wherever possible to quantify the significance of any bad impact on the community and environment likely to be affected by the  development activity;
  3. To formulate and incorporate appropriate abatement and mitigating measures into the development plan;
  4. To determine appropriate and effective programmes for monitoring environmental compliance and residual impact; and
  5. To identify wherever possible, the environmental costs and benefits of the development activity.

The benefits of environmental impact assessment impacts include the following:

  1. It allows the project team to systematically analysis the potential environmental problems from a proposed development, and to identify key areas which require special consideration for environmental controls;
  2. It presenting information needed by authorities in a way structured and facilitate decision making process and allow permits and approvals;
  3. Costs and time can be cut down by identifying and quantifying primary and secondary consequences which may require the introduction of expensive pollution control measures, compensation or other cost at a later date;
  4. It helps in establishing long term management objectives and plans, and enhancing organisation’s environmental image;
  5. A project that has been determined to suit the local environment most likely can be finished on time and within budget, and can also avoid difficulties along the way;
  6. A project that maintains and conserves the natural resources it relies upon will continue to be sustainable for many years to come; and
  7. A project that yields benefits with no serious environmental problems is more likely to bring credit and recognition to its proponent.[1] 


Kindly visit the Environment Protection Department Sabah at http://www.sabah.gov.my/jpas/ for further details.

Reference

  1. Handbook on Environmental Impact Assessment in Sabah, Second Edition. 2005. Last accessed on 12 November 2012 athttp://www.sabah.gov.my/jpas/Assessment/default.htm.

Traditional and Complementary Medicine Practice Guidelines on Herbal Therapy as Adjunct Treatment for Cancer 1st ed, 2009

On 11th January 2006, the Malaysian Cabinet had approved the establishment of the Traditional and Complementary Medicine (T&CM) Unit in three hospitals in Malaysia: Kepala Batas Hospital (Penang), Putrajaya Hospital (Putrajaya) and Sultan Ismail Hospital (Johor Bahru). This pioneer project focuses on the integration of T&CM into the existing healthcare delivery system.

This T&CM unit initially provides Malay Traditional massage, acupuncture and herbal therapy as an adjunct treatment for cancer.

Objective of these Guidelines

The main objective of these guidelines is to promote the rational usage of herbal therapy as an adjunct treatment for cancer. Adjunct means as a supporting treatment for chemotherapy and radiotherapy. The aim of herbal therapy is to reduce the side effect of cancer treatment, improve body immune system and exert synergistic effects.

Types of cancer

The focus will be on the six types of the most common cancers in Malaysia: the breast, lung, cervix, nasopharynx, colorectal and liver. This focus may be extended to other types of cancer if required.

Category of patients

  • Newly diagnosed cancer patients on radiotherapy or chemotherapy or surgery.
  • Patients completed chemotherapy with recurrence.
  • Advanced stage cancer on palliative treatment.
  • Cancer patients who refused medical treatment.

Standard of Practice

  • All cancer patients who seek for adjunct treatment at the T&CM Unit should be referred by a medical oncologist or a specialist treating cancer cases.
  • T&CM oncologist shall attend to patients in the T&CM Unit.
  • T&CM oncologist shall make an assessment on patient’s current mode of treatment and prescribe the necessary herbal products.
  • T&CM oncologist shall document all the relevant diagnostic indicators.
  • For a referral of new cases, the medical oncologist or related specialist shall provide the following information:
    1. Compete diagnosis with stages
    2. Laboratory profiles
    3. Radio-imaging reports
    4. Chemotherapy and radiotherapy regimes
    5. Other relevant information
  •  The standard treatment card and the prescription sheet of herbal therapy for complementary cancer treatment shall be used. 

Consultation Sessions

Consultation hours shall be from 8.00am to 5.00pm on working days and history taking shall be done to determine the suitability for herbal therapy. If the patient is found to have an acute illness or new medical complaints, T&CM oncologist are required to send the patient to emergency department for medical evaluation. T&CM oncologist is responsible to maintain surveillance on the management of patient on long term follow-up according to needs. Patients’ records must be kept for future references.

Treatment Proper

The treatment and management of patient must be done properly according to protocol. The lists of finished herbal formulation and single herbs extract powder for treatment must be standardized. The frequency and total duration of follow-ups are tailor-made to the individual’s necessity. Some examples of herb-drug interaction and herb-herb interaction are shown in this guideline.

Procurement and Storage of Formulated Herbal Products

All herbal products must contain ‘halal’ ingredient and be accompanied with their own Certificate of Analysis (COA) and passed all relevant tests. All the finished products of traditional Chinese herbs must be stored in a proper storage with updated inventories.

Dispensing of Herbs

Dispensation of formulated herbs shall be carried out by the trained pharmacist under close supervision of T&CM oncologist. Proper labelling, instructions of usage and name of ingredients must be clearly stated on the container and also at the packaging of the herbs.

Others

a) The fee charges follow the existing fee act or other relevant regulations.

b) The T&CM oncologist may send progress report of the patient to relevant specialist when required.

c) The T&CM oncologist may participate in research involving herbs when required.[1]


Kindly visit the Traditional and Complementary Medicine Division, Ministry of Health Malaysia for further details at http://tcm.moh.gov.my/v4/.

Reference

  1. Traditional and Complementary Medicine Division, Ministry of Health Malaysia. Traditional and Complementary Medicine Practice Guidelines on Herbal Therapy as an Adjunct Treatment for Cancer. First Edition September 2009.