Malaysia's National Pharmaceutical Regulatory Agency (NPRA) operates the national pharmacovigilance programme.
Core official resources
- NPRA — national regulator, product information and safety communications.
- Reporting ADR / AEFI — current reporting channels for suspected adverse drug reactions and AEFIs.
Practical use
NPRA asks healthcare professionals to report all suspected ADRs and AEFIs and currently supports electronic reporting as well as manual submission. Industry users should rely on NPRA's current pharmacovigilance guidance and authenticated systems for company-specific reporting rather than extrapolating from the healthcare-professional route.