DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)SECTION A: GENERAL OVERVIEW1. INTRODUCTIONThe Control of Drugs and Cosmetics Regulations (CDCR) 1984 were promulgatedunder the Sale of Drugs Act 1952. The Authority (known as Drug Control Authority,DCA) established under these Regulations, is tasked with ensuring the quality, safetyand efficacy of medicinal products through the registration, including quality control,inspection & licensing and post-registration activities. The National PharmaceuticalControl Bureau (NPCB) acts as the secretariat to the Authority.Under the CDCR 1984, Regulation 7(1): Except as otherwise provided in theseRegulations, no person shall manufacture, sell, supply, import, possess or administerany product unless:(a) the product is a registered product; and(b) the person holds the appropriate licence required and issued under theseRegulations.The phases of implementation for product registration are as shown in Figure 1 below:* 1 st July 2012:All manufacturers shall be certified for GMP as directed via Directive Arahan di Bawah Peraturan29, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 1 Tahun 2012Reference: Circulars Bil (25) dlm BPFK/PPP/01/03 Jld 1 and Bil (96)dlm.BPFK/PPP/01/03 Jld. 2** Voluntary registration of API commenced in April 2011, started with New Drug Products (NDP),followed by mandatory registration of API for NDP which were implemented in January 2012. Asfor Generics, the mandatory registration of API will be announced at a later date.National Pharmaceutical Control BureauFirst Edition, January 201324