Regulatory Resources

Malaysia

Malaysian useful links & regulatory resources

Note that the national pharmaceutical regulatory agency was formerly known as the National Pharmaceutical Control Bureau (NPCB), and is now usually referred to as NPRA under BPFK. Older guidance documents still use the NPCB name.

BPFK — Biro Pengawalan Farmaseutikal KebangsaanNational Pharmaceutical Regulatory Agency. Drug registration, cosmetic notification, licensing. Ministry of Health Malaysia (KKM)Parent ministry for pharmaceutical and cosmetic regulation. CTFA MalaysiaCosmetic, Toiletry & Fragrance Association of Malaysia. HerbaXpress — FRIMReference point for the local herbal industry. FRIM — Forest Research Institute MalaysiaResearch on Malaysian forest species used in natural products. Pharmacy Board MalaysiaRelevant particularly for pharmacy-related professional and regulatory information.

Industry bodies

Industry associations & professional bodies

MOPI — Malaysian Organisation of Pharmaceutical IndustriesIndustry association representing pharmaceutical manufacturers in Malaysia. ISPE — International Society for Pharmaceutical EngineeringTechnical resource for pharmaceutical engineering and GMP practice. PDA — Parenteral Drug AssociationTechnical focus on sterile and parenteral manufacturing.

International

International regulators & inspection schemes

World Health Organization (WHO)International guidance on GMP, pharmaceutical quality and regulatory standards. ASEANRegional pharmaceutical regulatory harmonisation and related regulatory frameworks. International Council for Harmonisation (ICH)International guidelines relating to the quality, safety and efficacy of pharmaceutical products. NPRA's current materials reference ICH guidelines in pharmaceutical registration requirements. PIC/S — Pharmaceutical Inspection Co-operation SchemeReference GMP guidance used internationally, and the basis for much local GMP practice. TGA — Therapeutic Goods Administration (Australia)Australian regulator; useful as a neighbouring-market reference. US FDA — Food and Drug AdministrationUS regulator; reference for international GMP expectation. COSING — European Commission cosmetics databaseIngredient database for the EU cosmetic regulation. GLOBEinMEDGlobal Information Hub on Integrated Medicine.

These are external links

HBB does not control and is not responsible for the content of external sites. Always confirm current requirements against the latest guidance document issued by the relevant authority — requirements change, and an out-of-date document is one of the most common causes of a delayed submission.

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