DRUG CONTROL AUTHORITY (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:
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Registration of pharmaceutical products and cosmetics
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Licensing of premises for importer, manufacturer and wholesaler
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Monitoring the quality of registered products in the market
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Adverse Drug Reaction Monitoring
TERMS OF REFERENCE (TOR)
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.
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IMPLEMENTATION
The Control of Drugs and Cosmetics Regulations 1984 empowers the DCA to implement the registration scheme in phases as follows:
1 NOVEMBER 1985
PHASE 1
Pharmaceutical products which contain scheduled poisons as defined in the Poisons Act 1952
1 NOVEMBER 1985
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 JANUARY 1993
1 AUGUST 1991
PHASE 4
Cosmetics
(Hair dyes containing phenylenediamine, toluenediamine, salt and derivatives)
(Hair dyes containing phenylenediamine, toluenediamine, salt and derivatives)
1 FEBRUARY 1996
PHASE 4
Cosmetics
(tooth whiteners containing hydrogen peroxide / carbamide peroxide)
(tooth whiteners containing hydrogen peroxide / carbamide peroxide)
1 FEBRUARY 1996
1 FEBRUARY 2002
PHASE 4
Cosmetics
(all cosmetic products other than listed above)
(all cosmetic products other than listed above)
1 JANUARY 2008
PHASE 4
Cosmetics
Cosmetics registration was replaced by the Notification Procedure
Cosmetics registration was replaced by the Notification Procedure
1 JANUARY 2008
AUGUST 2007
PHASE 5
Veterinary
JANUARY 2012
PHASE 6
New Chemical Entity (NCE)
JANUARY 2012
Updated by :
Nor Lisa Assakina Jamil, Product & Cosmetic Regulatory Coordination Section (20 December 2023)
