DRW Monthly
June 2010
Issue No. 42

Malaysian Drug Manufacturing and Registration Requirements

Over the past decade, Malaysia has developed a keen interest in promoting the local production of drugs, particularly in the areas of biotechnology and off-patent products. The government is now offering incentives, including tax exemptions for biotech companies, and providing the necessary infrastructure to encourage multinational biopharmaceutical companies to establish manufacturing operations within the country. Malaysia's new biotech initiative, its active involvement in global harmonization efforts combined with its own progressive pharmaceutical regulatory developments has attracted a growing number of companies seeking to invest in manufacturing plants and research projects.(1)

Under the direction of the National Pharmaceutical Control Bureau (NPCB) since 1985, Malaysia's current pharmaceutical regulatory system has advanced concurrently with the development of international standards. The issuance of the Control of Drugs and Cosmetics Regulations in 1984 laid the legislative foundation for the systematic regulatory control of pharmaceuticals in Malaysia. This regulation also established the Drug Control Authority (DCA) whose main task is to ensure the safety, quality and efficacy of marketed pharmaceuticals, health and personal care products. The DCA's key responsibilities include registering pharmaceutical products; licensing importers, manufacturers and wholesalers; and monitoring the quality of registered products on the market and overseeing adverse drug reactions.(2)

Companies are required to register all pharmaceutical products and traditional medicines in Malaysia. However, only local distribution companies may submit a drug registration application. Foreign companies must appoint a local agent, also known as the Marketing Authorization Holder (MAH), who oversees all matters pertaining to registration and will also retain the registration certificate. The MAH is responsible for submitting the product application and ensuring the product's quality, safety and efficacy.(3)

At this time, pharmaceutical products may only be registered online through NPCB's website using the Quest2 online submission system. A separate application is required for each product to be registered. However, products differing only in their packaging materials or pack sizes may be registered in a single product application.

The following documents are also required for inclusion with the application:

• Letter of authorization from the product owner composed on the owner's letterhead and dated/signed by the company's managing director or president;
• Letter of authorization from the contract manufacturer (and any subcontractors) if the product is contract manufactured; the letter should indicate product name, manufacturer's name and address.
  

Additional imported product requirements:

• Certificate of Pharmaceutical Product (CPP) from the pharmaceutical authority in the country of origin. CPP may be substituted with a Good Manufacturing Practice (GMP) certificate or manufacturing license with either (1) a CPP from the product owner's country or (2) CPP from country of release;
• Free Sale Certificate and GMP certificate is required for traditional medicines, dietary supplements and external personal care products.(4)

Conclusion

As earlier stated, in the past decade Malaysia has concentrated its efforts on increasing product innovation and promoting the establishment of new drug manufacturing operations. With the country's acceptance as the 26th member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspections Cooperation/Scheme in 2002, it's GMP and marketing regulatory procedures became aligned with the regulatory frameworks of most developed countries. In addition, the NCPB has been recognized by the Association of Southeast Asian Nations (ASEAN) Technical Cooperation among Developing Countries as the regional training center for quality control of pharmaceuticals and has successfully conducted this training since 1986.(5) Malaysia's active role in these global pharmaceutical regulative initiatives has significantly strengthened its status as a highly regarded and integral player in the international community.

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