Voluntary Good Pharmacovigilance Practices (GVP) Inspection on Pharmaceutical Product Registration Holders (PRHs)


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The National Pharmaceutical Regulatory Agency (NPRA) will be conducting Good Pharmacovigilance Practices (GVP) Inspection on pharmaceutical product registration holders (PRHs). The implementation of the GVP Inspection will be done in phases, starting with a voluntary phase from January 2023. The main aim of the voluntary GVP Inspection is to facilitate PRHs to build and strengthen their pharmacovigilance systems and practice in accordance with the Malaysian Guidelines on GVP prior to the actual GVP Inspection in the future.

A guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection" has been prepared as a reference for PRHs who wish to join the voluntary GVP inspection.  Please refer to the guidance document for further details on the mechanism of GVP Inspection.

The voluntary GVP Inspection announcement letter and guidance document are available here.