Drug Control Authority (DCA)
About the DCA
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
Terms of reference
The Drug Control Authority (DCA) is a body set up under the Control of Drugs and Cosmetics Regulation 1984 and as such its responsibility, role and mandate are defined by law. DCA provides the general principles of safety, quality and efficacy that form the basis for the evaluation and eventual registration of products.
Documents
The Authority's terms of reference, and the meeting calendar for the year.
Implementation
The Control of Drugs and Cosmetics Regulations 1984 empowers the DCA to implement the registration scheme in phases as follows:
| Date | Phase | Scope |
|---|---|---|
| 1 November 1985 | Phase 1 | Pharmaceutical products which contain scheduled poisons as defined in the Poisons Act 1952 |
| 1 August 1988 | Phase 2 | Pharmaceutical products that do not contain scheduled poisons, ither than traditional medicines |
| 1 January 1993 | Phase 3 | Traditional Medicines |
| 1 August 1991 | Phase 4 | Cosmetics Hair dyes containing phenylenediamine, toluenediamine, salt and derivatives |
| 1 February 1996 | Phase 4 | Cosmetics Tooth whiteners containing hydrogen peroxide / carbamide peroxide |
| 1 February 2002 | Phase 4 | Cosmetics All cosmetic products other than listed above |
| 1 January 2008 | Phase 4 | Cosmetics Cosmetics registration was replaced by the Notification Procedure |
| August 2007 | Phase 5 | Veterinary |
| January 2012 | Phase 6 | New Chemical Entity (NCE) |