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Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA

On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection" has been prepared as a reference for Pharmaceutical Product Registration Holders (PRHs) who wish to join the voluntary GVP inspection.


The National Pharmaceutical Regulatory Agency (NPRA) will be conducting Good Pharmacovigilance Practices (GVP) Inspection on pharmaceutical product registration holders (PRHs).

The main vision 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.


This guidance document is intended to provide detailed information on the Malaysian voluntary GVP Inspection programme. It also serves as a guide for the PRHs that choose to participate in this programme. The PRHs are required to provide the Pharmacovigilance System Summary (PVSS) and up-to-date Pharmacovigilance System Master File (PSMF) which will be used in the voluntary GVP Inspection


The implementation of the GVP Inspection will be done in phases, starting with a voluntary phase from January 2023.


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

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