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General Information
In Malaysia, the main agency responsible for regulating pharmaceuticals/drugs is the Drug Control Authority (DCA), which is the executive body established under the Control of Drugs and Cosmetics Regulation 1984 (CDCR) and managed by the National Pharmaceutical Control Bureau (NPCB) [1][2]. The main responsibility of the DCA is to ensure that pharmaceuticals/drugs that are marketed in Malaysia are safe, efficacious and quality and the process of evaluation until registration of the products are under DCA’s purview [1]. This main task is achievable through:
- Registration of pharmaceutical products and cosmetics
- Licensing of premises for importer, manufacturer and wholesaler
- Monitoring the quality of registered products in the market
- Adverse Drug Reaction Monitoring [2]
The Control of Drugs and Cosmetic Regulations 1984 was promulgated under the Sale of Drugs Act 1952 and were first implemented on November 1, 1985 (amendment on 2007) [3] [4]. In line with the establishment, all drugs in pharmaceutical dosage forms and cosmetics have to be registered before sales and marketing is permitted in the country, as mentioned under Clause 7 (1) which is “no person shall manufacture, sell, supply, import, possess or administer any products unless the product is a registered product and the product holds the appropriate licence required and issued under these Regulations” [3].
The phases of implementation for product registration are as shown as below:
- Phase 1: Registration August 1985 (Prescription drugs)
: Licensing May 1987 - Phase 2: Registration 1988 (Over the counter)
: Licensing 1992 - Phase 3: Registration January 1992 (Traditional medicine)
: Licensing Manufacturer Importers January 1999 - Phase 4: Registration February 2002 (Cosmetics)
: Licensing January 2004 - Phase 5: Registration August 2007 (Veterinary)
: Licensing 1 January 2012 - Phase 6: Registration beginning with New Chemical Entity January 2012 (Regulator control of Active
pharmaceutical ingredient (API))
: No licensing requirements as registration of API is linked to products [2] [4].
The registration process involves quality control (sample testing are required for natural products), Good Manufacturing Practice (GMP) Inspection and licensing application for import and/or wholesale license as well as post-registration process of medicinal products [4]. Furthermore, a company or person responsible for placing their products must notify the Director of Pharmaceutical Services (DPS) through NPCB. Prior to apply the manufacturing license, as well as product registration / notification, they must ensure that the products are manufactured in facilities that comply with the ASEAN Guidelines on GMP and Malaysian Good Storage Practice (GSP) or its equivalent [4] [6].
Attached with the regulation are the required forms to be filled for registration purposes:
- Form 1: Registration Certificate
- Form 2: Manufacture’s License
- Form 3: Wholesaler’s License
- Form 4: Clinical Trial Import License
- Form 5: Import License
For more information on CDCR, it shall be read in conjunction with the other relevant legislations where applicable, governing pharmaceuticals/drugs for human use in Malaysia, which include:
- Drug Registration Guidance Document (update in 1 January 2013) [4]
- Sale of Drug Act 1952 (Laws of Malaysia Act 368) (revised in 1 July 1989 and incorporating all amendments up to 1 January 2006) [5]
- Guidelines for Control of Cosmetic Products in Malaysia May 2009 (second revision) [6]
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Contact Details
National Pharmaceutical Control Bureau (NPCB)
Ministry of Health, Malaysia
Lot. 36, Jalan Universiti,
46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia
Phone: +603-7883 5400
Fax: + 603-7956 2924, 7956 7075
Website: http://www.bpfk.gov.my/
References:
- Ministry of Health. National Pharmaceutical Control Bureau. Drug Control Authority. Last accessed on 30 Jan 2013 at http://portal.bpfk.gov.my/view_file.cfm?fileid=124
- National Pharmaceutical Control Bureau. The Drug Control Authority. Last accessed on 4 Feb 2013 at http://portal.bpfk.gov.my/index.cfm?&menuid=148&parentid=9
- Clinical Research Centre. Control of Drugs and Cosmetics Regulation 1984. Last accessed on 29 Jan 2013 at http://www.crc.gov.my/guidelines/pdf/Control%20drugs%20%26%20cosmetics%20regulation.pdf
- Ministry of Health. National Pharmaceutical Control Bureau. Drug Registration Guidance Document. Last accessed on 15 Feb 2013 at http://portal.bpfk.gov.my/aeimages//File/Complete_DRGD_with_appendices_updated.pdf
- The Attorney Generals’s Chamber of Malaysia. Sale of Drugs Act 1952. Last accessed on 15 Feb 2013 at http://www.agc.gov.my/Akta/Vol.%208/Act%20368.pdf
- Ministry of Health. National Pharmaceutical Control Bureau. Guidelines for Control of Cosmetic Products in Malaysia. Last accessed on 15 Feb 2013 at http://portal.bpfk.gov.my/view_file.cfm?fileid=439
