Malaysia

Pharmacovigilance in Malaysia is regulated by the National Pharmaceutical Regulatory Agency (NPRA). The official Malaysian Guidelines on Good Pharmacovigilance Practices for Product Registration Holders require every Product Registration Holder (PRH) to establish and maintain an appropriate pharmacovigilance system. A Responsible Person for Pharmacovigilance (RPPV) must be permanently and continuously available; the RPPV should preferably be based in Malaysia, and where the RPPV is based outside Malaysia a local contact person based in Malaysia must be appointed and remain contactable. PRHs must prepare a Pharmacovigilance System Summary and PSMF (subject to the guideline’s stated product-category exceptions) and make the PSMF available to NPRA when required. For Malaysian ICSRs, fatal or life-threatening serious reports must be submitted as soon as possible and no later than 7 calendar days, with completion within a further 8 days; other serious reports are due within 15 calendar days and non-serious reports within 30 calendar days. The framework also covers PSUR/PBRER, RMP and risk-minimisation obligations and risk-based pharmacovigilance inspections. NPRA’s 2025 GVP addendum should be read together with the guideline. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.