The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the first edition of the “Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection” in March 2022.
The objective of this document is to assist product registration holders (PRHs) to create and continuously improve their pharmacovigilance systems and practices.
NPRA will aim to review the overall procedures, systems, personnel, and facilities set in the pharmacovigilance system of a company, to determine a company’s ability to comply with pharmacovigilance regulatory obligations.
PRHs are required to submit the Pharmacovigilance System Summary (PVSS) to express interest to join the inspection programme. The PVSS is a document with description of the company’s pharmacovigilance system. The PVSS will be used by NPRA to conduct their risk-based assessment and only those short-listed can take part in the programme.
There are three methods for the inspection, namely remote, hybrid (combination of remote & on-site) and on-site. NPRA will decide on the method after communicating with the PRHs.
More details can be found in: “Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection, First Edition, March 2022”: https://www.npra.gov.my/easyarticles/images/shared/FV/Guidelines/Finalised-Guidance-Document-on-Voluntary-GVPI-14032022.pdf