Malaysian Pharmacovigilance Guidelines 2nd Edition

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Second Edition

  • The Malaysian Guidelines for the Reporting & Monitoring 2002 has been updated to align with current international requirements in adverse drug reaction (ADR) reporting and safety monitoring for medicinal products.
  • In addition, this guideline has been updated to explain in detail on ADR reporting for Healthcare Professionals and Product Registration Holders.
  • This guideline will be implemented with immediate effect.

(Refer letter to Product Registration Holders, Ruj.Kami: (73)dlm.BPFK/17/FV/4 JILID51, Date: 5 September 2016)



National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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