- National Regulatory Conference 2018 (NRC 2018)
- NOTICE: NEW Terms in Advertisement Application for Approvals of MAB
- Guidelines on Conducting Research under Pharmaceutical Services Programme in Ministry of Health Malaysia
- Panduan Penggunaan Ubat-ubatan yang Mengandungi Unsur Tidak Halal
- 10th National Pharmacy R&D Conference 2018
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor.
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Phone: 603-7841 3200
Fax: 603-7968 2222
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Pharmacy service came into existence in the country since 1951 with the enforcement of the Registration of Pharmacist Act 1951, Poisons Act 1952 and Dangerous Drugs Act 1952. The primary task of the pharmacy service prior to independence was confined to the procurement, storage and distribution of drugs from the United Kingdom through the Crown Agents.
Under the Second Malaysia Plan (1961-1965), the Government Pharmaceutical Laboratories and Stores (GPLS) Complex was set up in Petaling Jaya in 1969. This was the landmark development in pharmaceutical service in the country. It had successfully provided a reliable source of cheap, cost-effective and good quality pharmaceuticals for the medical and health programmes of the Ministry of Health, which emphasizing on the rural health service.
Pharmaceutical Chemistry Division was officically established in 1969 to cater for the rising needs of the pharmaceutical services. Pharmacists then were known as Pharmaceutical Chemistry Superintendant. The division was officially named the Pharmaceutical Services Division on 1st January 1974 in recognition of the expanding role of the pharmaceutical service in the health sector.
The Pharmacy Enforcement Unit was formed on 1st January 1976 under the Pharmaceutical Services Division to carry out the enforcement of legislations pertaining to pharmacy and the pharmaceutical trade in the country in a more efficient approach.
In the 1970's, the scope of the service was extended to cover the quality assurance of pharmaceuticals in the country. The National Pharmaceutical Control Laboratory, which was later renamed as the National Pharmaceutical control Bureau was set up in October 1978 under the Second Malaysia Plan to perform this regulatory responsibility.
The promulgation of the Control of Drugs and Cosmetics Regulations in June 1984 marked the dawn of the regulatory era in Malaysia. This laid the groundwork necessary towards moulding a systematic pharmaceutical regulatory system in Malaysia. In January 1985, the Drug Control Authority (DCA) was established under the chairmanship of the Director General of Health Malaysia, with a mission of ensuring, quality, safety and efficacy of pharmaceutical products prior to marketing. To accomplish this goal, the DCA through its Secretariat, the National Pharmaceutical Control Bureau (NPCB) undertakes the regulatory functions such as product registration, sample analysis, inspection and licensing, post-marketing surveillance and ADR monitoring.
The Pharmacy Board established under the Registration of Pharmacists Act 1951 admitted 20 pharmacists into its register in 1952. At the time of independence in 1957 there were 23 registered pharmacists in the public sector. Due to the lack of pharmacists and the urgent need to provide and maintain a basic pharmaceutical service in public hospitals and health clinics, the Dispenser's (now Pharmacy Assistant) Training School was set up as a stopgap measure.
The shortage of pharmacists continues to affect the expansion of pharmacy service in the country in particular, the provision of clinical and pharmaceutical care services to patients. As a long term measure, the compulsory service was introduced in the public sector, through the amendment to the regulations of the Registration of Pharmacists Act 1951 in 2003. The Registration of Pharmacists (Amendment) 2003 was enforced on 2nd September 2004.