Dr A. bin Ahmad, Malaysia

The promulgation of the Control of Drugs and Cosmetic Regulations in June 1984 marked the commencement of an era of regulatory control in Malaysia. Evaluation of products, licensing of premises, quality control assessments, monitoring of adverse drug reactions, post-marketing surveillance and dissemination of information have all been woven into the fabric of current regulatory activities.

Like the vast majority of developing countries, Malaysia has no plasma fractionation facilities to manufacture plasma-derived products and relies upon registration and licensing of imported products. In addition, since 1990, the National Blood Transfusion Centre has established contracts on plasma fractionation with the Commonwealth Serum Laboratories (CSL) of Australia.

Although the responsibility of assuring quality, safety and efficacy of these imported products lies with the manufacturers and is guaranteed by the licensing authority of the country of manufacture, the Malaysian Drug Control Authority has a crucial role in ensuring that the potency, safety and efficacy of these imported products comply with regulatory requirements.

A rigorous regulatory framework backed by surveillance and enforcement is important for ensuring quality, safety and efficacy of plasma-derived products for non-producing countries. However, there are several pertinent issues of concern that must be resolved to further improve the present regulatory system. Of prime importance is the issuance of Batch Release Certificates by the licensing authority of the country of manufacture. With recent advancements in information technology, electronic networking among various national control authorities (NCA) serves as a useful approach for non-producing countries in assuring quality and safety of plasma-derived products.

Even more importantly, cooperation and harmonization among the players involved, namely the regulators, enforcement officers, product registration holders and importers, will facilitate the assurance of quality and safety of plasma-derived products.