Pharmaceutical products, pharmacy practice and medicine use are governed by laws and regulation. Under the Pharmaceutical Services Programme, there are three major activities governing and controlling products, pharmacy practice and use of drugs. They are the Regulatory, Enforcement and Pharmacy Practice activities.

Quality Assurance (Regulatory)

The Ministry of Health Malaysia (MOH) has put in place a well-structured and comprehensive regulatory system. The main objective is to ensure product quality, efficacy and safety, with the ultimate aim of protecting and promoting public health.

For this purpose, the Control of Drugs and Cosmetics Regulations 1984 was promulgated under the provision of the Sale of Drugs Act 1952. The Regulations provide for the establishment of the Drug Control Authority (DCA) under the Ministry of Health to regulate the pharmaceutical, traditional and cosmetic industry to achieve the stated objectives.

The DCA, an executive committee which is responsible for product registration and licensing of manufacturers, importers and wholesalers was established in 1985. The National Pharmaceutical Control Bureau (NPCB) is the operational arm and has served well as the Secretariat to the DCA.

The role of NPCB as the regulatory agency for pharmaceuticals, traditional medicines and cosmetics

In order to ensure products that reach the general public are safe, efficacious and of quality, many steps are taken.

Before a product is made available to the Malaysian market, it has to undergo various scrutiny and evaluation which are performed by the NPCB itself. Every product that enters has to be registered by NPCB. Registration of the products is necessary as it is needed to keep track of the products that are available for public use.

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