Ensuring Quality of Products
Ensuring Quality of Products
The Ministry of Health Malaysia (MOH) has put in place a well-structured and comprehensive pharmaceutical 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 serves as the Secretariat to the DCA.
The role of NPCB as the regulatory agency is to ensure the quality, efficacy and safety of pharmaceutical products, traditional products and cosmetics. It achieves its objectives through registration, notification and licensing scheme. Before a product is made available to the Malaysian market, it has to undergo various stages of evaluation by the NPCB based on the principles of quality, efficacy and safety.
Apart from that, the NPCB also monitors registered products through surveillance and pharmacovigilance activities. In view of its technical expertise and training capabilities, the NPCB was recognised by the World Health Organization (WHO) as a Collaborating Centre in the Regulatory Control of Pharmaceuticals on the 10th of May 1996. As a WHO Collaborating Centre NPCB provides training in the fields of pharmaceutical quality assurance and regulatory affairs to fellows from other National Regulatory Agencies. The NPCB, as the National Drug Safety Monitoring Centre was accepted as the 30th member of the World Health Organization (WHO) Drug Safety Monitoring Programme in 1990. Through this programme, adverse drug reaction (ADR) reports which have been received and screened by NPCB will be included in the WHO database. In addition to this, the NPCB also successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002 in recognition of the high level of its Good Manufacturing Practice (GMP) inspection system.
Since then, NPCB has been actively involved in international GMP and Quality Assurance programmes organised by PIC/S as well as WHO. To further improve the quality of services provided to its clients, the NPCB continues to strive towards upgrading its Quality Management System cumulating in the successful upgrading of its MS ISO certification from version MS ISO 9001:2000 to the latest version MS ISO 9001:2008 as well as receiving accreditation to the MS ISO/IEC 17025: 2005 in the fields of chemical and microbiological testing.