International Regulatory Cooperation for Herbal Medicine-The Second Meeting of IRCH Report 2007

International Regulatory Cooperation for Herbal Medicine-The Second Meeting of IRCH Report 2007

Background

IRCH which stands for International Regulatory Cooperation for Herbal Medicines was officially established in early 2006 under the auspicious of the World Health Organisation (WHO). It is a network of national and regional/subregional regulatory authorities responsible for the regulation of herbal medicines.

In 2002, 120 out of 140 countries which participated in the WHO Global Survey on National Policy of Traditional Medicine had requested WHO to support information sharing on regulatory issues and current Traditional Medicine/Complementary and Alternative Medicine data. Responding to this request, WHO formed a working group consisting of national regulatory authorities from several countries as well as other regional/sub-regional/inter-regional regulatory authorities. The first meeting was held on 28-30 November 2005 in Ottawa, Canada to discuss issues relating to the regulation of herbal medicine and an agreement was reached by consensus to establish a network to be named International Regulatory Cooperation for Herbal Medicines (IRCH). 13 countries and 2 regional bodies became members of this network and elected their Focal Points (persons who act as the main IRCH contacts for their respective country/region), whilst WHO played the role of a coordinator between member countries.

The second WHO working group meeting held on 23-25 October 2006 in China was regarded as the First Annual Meeting of IRCH. 12 member countries and 4 regional regulatory agencies and regulatory authorities as well as observers participated in this meeting. The participants reviewed, clarified and finalised the mission, objectives and activities of IRCH.

Synopsis on the Second Annual Meeting of IRCH

The second meeting of IRCH was held in Kuala Lumpur, Malaysia on 24-26 July 2007 attended by 18 member countries of IRCH and representatives of regional/sub-regional/inter-regional regulatory cooperation groups including several observers from various regulatory authorities.

The meeting focused on information exchange related to herbal medicines among members through their respective Focal Points and proposed activities.

Member countries are encouraged to exchange the following information using MedNet IRCH website:

  • Lists of registered or licensed herbal medicines and other herbal products;
  • Short descriptions and lists of positive or negative lists of herbal ingredients;
  • Herbal ingredients including plants and herbal preparations listed in national pharmacopoeias and formularies;
  • Policies, legislation and mechanism related to the export of herbal medicines;
  • Definition of traditional and/or herbal medicines as they differ between countries/regions
  • Information on the requirements for safety, quality and efficacy of traditional and/or herbal medicines;
  • Information on the requirements for safety, quality and efficacy of food/health supplements;
  • List of medicinal plants whose quality have been approved and controlled under Good Agricultural Practice (GAP) guidelines.

Adulteration and/or counterfeiting, misidentification and substitution of herbal medicines

This issue was also discussed and members were asked to:

  • identify examples of such products commonly seen in member countries/region;
  • health risks associated with these products;
  • share steps and methods to evaluate and identification of these products;
  • provide links to the related websites on current initiatives undertaken by member countries to control the adulteration and counterfeiting of herbal products.

WHO has plans to support improvements in reporting of adverse reaction to herbal medicines by providing training to related agencies that collect these reports including to reporting individuals e.g. physicians, pharmacists and herbal medicine dispensers.

Proposed future activities 

  • WHO presented planned activities for the next two (2) years, including a second WHO Global Survey on National Policies on Traditional Medicine and regulation of herbal medicine. Members were requested to complete a list of questionnaires and return the comments to WHO and where necessary, liase with the relevant authorities/agencies on matters relating to policies and practices.
  • The 13th International Conference of Drug Regulatory Authorities (ICDRA) is scheduled to be held in Bern, Switzerland in 2008 during which the following topics were suggested for discussions:
  • global issues relating to adulteration, contamination and quality of herbal medicine;
  • sharing of information between member countries regarding regulations on herbal medicine;
  • Workshop on setting of criteria for evaluation of herbal medicine application by sharing ideas and experience between member countries;
  • stability, shelf life and storage of herbal medicine;
  • and evaluation of herbal medicine which do not have strong scientific evidence. 
  • Members agreed to nominate at least one additional Information Focal Point as back-up to ensure quick response in the event the primary Information Focal Point is not available. 
  • WHO made a commitment to enhance and strengthen the security of MedNet IRCH communication. 
  • Suggestions to form working groups to draft definitions, standards and criteria on quality and safety of herbal medicines will be discussed in the next meeting. [1]

Reference:

  1. World Health Organisation. Summary Report of the Second Meeting of International Regulatory Cooperation for Herbal Medicines (IRCH). 2007.