The Malaysian National Pharmaceutical Regulatory Agency (NPRA) announced that it will implement a new good pharmacovigilance (GVP) inspection program at the beginning of 2023 with a voluntary phase. These inspections ensure that manufacturers of pharmaceutical products and their affiliates conform to the NPRA’s post-marketing quality requirements and GVP guidance. Although the primary focus of these risk-based inspections will be activities taking place in Malaysia, the NPRA may also inspect global data, if appropriate. Companies interested in reinforcing their pharmacovigilance practice via participation in the voluntary inspection program must submit a summary of their pharmacovigilance system to the NPRA for their consideration. If a company is shortlisted to participate in the GVP program, it will have to provide a more detailed dossier describing its pharmacovigilance system. Once the voluntary phase ends in the future, this new GVP inspection program will become mandatory.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.npra.gov.my/easyarticles/images/shared/FV/Guidelines/Finalised-Guidance-Document-on-Voluntary-GVPI-14032022.pdf