OBJECTIVES
The Drug Control Authority (DCA) is the executive body established under the Control of Drugs and Cosmetics Regulations 1984.The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia.
This objective is being achieved through the following:
- Registration of pharmaceutical products and cosmetics
- Licensing of premises for importer, manufacturer and wholesaler
- Monitoring the quality of registered products in the market
- Adverse Drug Reaction Monitoring
IMPLEMENTATION
The Control of Drugs and Cosmetics Regulations 1984 empowers the DCA to implement the registration scheme in phases i.e.
Phase 1
Pharmaceutical products which contain scheduled poisons as defined in the Poisons Act 1952 (1st November 1985)
Pharmaceutical products which contain scheduled poisons as defined in the Poisons Act 1952 (1st November 1985)
Phase 2
Pharmaceutical products that do not contain scheduled poisons, other than traditional medicines (1st August 1988)
Pharmaceutical products that do not contain scheduled poisons, other than traditional medicines (1st August 1988)
Phase 3
Traditional medicines (1st January 1992)
Traditional medicines (1st January 1992)
Phase 4
Cosmetics
Cosmetics
- hair dyes containing phenylenediamine, toluenediamine, salt and derivatives (1 st August,1991)
- tooth whiteners containing hydrogen peroxide / carbamide peroxide (1st February,1996)
- all cosmetic products other than listed above (1st February 2002)
Phase 5
Registration - Veterinary (Aug 2007)
Registration - Veterinary (Aug 2007)
Phase 6
Registration beginning with NCE (Jan 2012)
Registration beginning with NCE (Jan 2012)
Notes ** Cosmetics registration was replaced by the Notification Procedure as of 1 Januari 2008
The DCA also ensures that all registered / notified products are labelled according to stipulated labeling requirements