Drug Approvals in Malaysia

Registration applications for 1,377 pharmaceutical products were processed by Malaysia's Drug Control Authority in 1994. Of these, 635 were approved, 569 were rejected, 149 applications were cancelled and 24 were deferred, according to the DCA's newsletter.

The DCA also notes that 37 products were recalled during 1994 for failing to meet quality and safety requirements, and that seven pharmaceutical factories were penalized and their manufacturing licenses temporarily suspended, for non-compliance with Good Manufacturing Practice requirements.

With the beginning of 1995, 10 years have passed since the DCA was established under Malaysia's Control of Drugs and Cosmetics Regulations 1984, reports the newsletter. Looking at what has been achieved over this period, it notes that implementation of the Regulations, which began in 1985, is well on schedule, with the first and second phases of the implementation schedule, covering prescription and over-the-counter products, having been completed. To date, the DCA says it has approved 6,349 prescription drug products, 3,968 OTC medicines and 148 hair-dye products.