Drug Registration In Malaysia

A total of 10,350 drugs and cosmetics had been registered with the Drug Control Authority of Malaysia under the Control of Drugs and Cosmetics Regulations at June 30, 1994, the closing date for products already on the market when registration commenced, the DCA reports. By June 30, about 15,000 applications for registration had been received. The commencement date for registration of products in Peninsula Malaysia was January 1, 1992, while for Sabah, Sarawak and the federal Territory of Labuan it was February 1, 1993.

The Authority is now registering traditional medicines, under Phase III of the regulations, and the closing date for applications for these products is December 31, 1994. Products which fail to submit an application on or before that date will be no longer permitted for manufacture, import or sale after that date. They will be treated like any other new products which require prior registration approval by the Authority before they can be manufactured or imported for distribution, says the DCA.

The DCA also reports that the following products classified as New Chemical Entities were approved for registration in Malaysia during January-June 1994: Bayer's Nimotop (nimodipine); Schering AG's Skinoren Cream (azelaic acid); Schering-Plough's Leucomax (recombinant methionyl human granulocyte-macrophage colony stimulating factor); Schering-Plough Canada's Elomet (mometazone); Janssen's Livostin (levocabastine); Ferring's Glypressin (terlipressin); Serono's Stilamin (somatostatin); Bristol Caribbean's Taxol for Injection Concentrate (paclitaxel); and Sandoz' Navoban (tropisetron).