Malaysia Announces Voluntary Pharmacovigilance Inspections From Jan 2023
Executive Summary
The Malaysian drug agency is inviting drug companies to voluntarily sign up to its new risk-based pharmacovigilance inspection program so that they can build and strengthen their internal systems before such inspections become mandatory.
The Malaysian drug regulator has announced plans for the phased roll-out of its new good pharmacovigilance (GVP) inspection program for companies with authorized pharmaceutical products, starting with a voluntary phase in January 2023.
The GVP inspections, which are a new activity for the National Pharmaceutical Regulatory Agency, aim to ensure that product registration holders (PRHs), and other parties employed by PRHs, are complying with obligations as laid out in the Malaysian GVP guideline and meeting all post-registration safety-related requirements.
The inspections will follow a risk-based approach and focus mainly on Malaysian activities, although inspection on global information will be conducted, when necessary, the NPRA said.
During the initial phase of the inspection program, participation by PRHs will be entirely voluntary. Details on how interested companies can join the NPRA’s GVP inspection program are explained in a new guideline.
The voluntary phase will allow the NPRA to “identify and address any gaps and challenges in conducting this new activity, particularly in this unprecedented pandemic situation” and prepare the ground for the roll-out of a full-fledged GVP inspection program in the future, the guideline said. It will also help companies build and strengthen their pharmacovigilance systems and practices in accordance with Malaysian GVP guidelines.
In view of the uncertainty posed by the ongoing COVID-19 pandemic, which may result in the introduction of travel and social distancing-related restrictions, the NPRA said it was open to undertaking remote, hybrid or on-site GVP inspections during the pandemic and “other crisis situations, which render on-site inspection not possible.” The preliminary voluntary phase will also help the NPRA test the feasibility and practicality of the different inspection methods.
Companies that choose to participate in the GVP program must provide the NPRA with a pharmacovigilance system summary (PVSS), briefly describing their pharmacovigilance system. Information in the PVSS as well as several other factors will be used by the agency in its risk-based approach to select which PRHs to prioritize for inspection.
Companies that are shortlisted for the inspection must provide the agency with, among other things, an up-to-date pharmacovigilance system master file (PSMF), providing a detailed description of the pharmacovigilance system used by the PRH with respect to one or more registered medicinal products.
More details on the inspection process and how the inspection findings will be categorized are discussed in the guideline.