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Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has released guidance about the requirements and procedures of good pharmacovigilance practices (GVP) in Malaysia. NPRA’s guidelines address topics such as the submission of reports of adverse reactions to drugs and vaccines.


This guideline is mainly adopted from the European Good Pharmacovigilance Practices and other GVP-related guidelines by other regulatory agencies were also referenced. This reference guide serves as a guide for the product registration holder to establish a pharmacovigilance system within their organisation framework.

The scope of pharmacovigilance in Malaysia includes (but is not limited to):


i. ADR/AEFI reporting by healthcare professionals, consumers, and PRH, collection of reports, and monitoring by PRH and the Authority.


ii. Safety profile monitoring through signal management process, as well as preparation and evaluation of Periodic Benefit-Risk Evaluation Report (PBRER) and Risk Management Plan (RMP).


iii. Risk Management System: a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to a medicinal product, including the assessment of the effectiveness of those interventions.


iv. Safety communication, for example, Direct Healthcare Professional Communication (DHPC) Letter, Package Insert (PI), websites, publications, and Consumer Medication Information Leaflet (RiMUP); to ensure product information is updated with latest safety information according to NPRA directives and circulars.


Check out this LINK for more information on Guideline.


Adverse Drug Reaction (ADR) / Adverse Event Following Immunisation (AEFI) Reporting Manual for Healthcare Providers provides. This guideline has been developed to outline the requirements and procedures for submission of adverse drug reaction (ADR) and adverse event following immunisation (AEFI) reports to the Drug Control Authority (DCA) for healthcare providers.


The requirement outline in this manual will help to improve the quality and standard of ADR/AEFI reporting in Malaysia.

Check out this LINK for more information on Guideline.


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