NPRA Malaysia Issues Updated Guidelines for Pharmacovigilance

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued two updated guidelines for pharmacovigilance in August 2021.  

The updated guidelines are: 

  • “Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders, First Edition, August 2021” (effective from the 1st of January 2022). 
  • “Adverse Drug Reaction (ADR) / Adverse Event Following Immunisation (AEFI) Reporting Manual for Healthcare Providers, August 2021” (effective immediately). 

These guidelines replace the existing guideline, “Malaysian Pharmacovigilance Guidelines 2nd Edition, 2016”, which was intended for both healthcare providers and product registration holders (PRHs). 

The updated guideline for PRHs outlines the requirements and procedures of GVP activities including but not limited to the submission of ADR and AEFI reports, and the submission of information regarding product safety to the Drug Control Authority (DCA).   

A new section (Part 6) on Pharmacovigilance System Master File (PSMF) has been included in the guidelineAll PRHs are required to prepare both Pharmacovigilance System Summary (PVSS) and PSMF. However, submissions of PVSS and PSMF to the Authority are applicable only to PRHs involved in Good Pharmacovigilance Practice Inspection (GVPI) and the timeline of submission will be notified by the NPRA. Details of Malaysian GVPI will be announced in the future. 

The updated guideline for healthcare providers outlines the requirements and procedures of reporting for ADR as well as reporting and investigation of AEFI. It also contains information on the new causality assessment for AEFI. 

More details can be found in: 

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