DRUG APPROVAL CHANGE IN MALAYSIA

At the end of 1991, the Drug Control Authority of the Malay- sian Ministry of Health implemented new procedures for submission of drug registration applications, and also for samples for registration.

These new procedures are aimed at reducing the time spent on processing and evaluating applications, according to the DCA. Previously, it says, the time taken to evaluate and process an application for registration was about six to 18 months, or even longer. Under the new procedure, the DCA hopes to process applications within three to six months, provided that the application file is submitted complete. However, submissions for New Chemical Entities are expected to take longer.

In order for the change to be implemented, the DCA secretariat will not be accepting applications for registration between December 1991 and May 1992, although samples for new submissions have been acceptable from January onwards.