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However, when a product that has been widely distributed or poses a serious health hazard is recalled, NPRA may do so if the agency determines it is necessary to protect consumers. References: 1) Drug Registration Guidance Document (DRGD) 2) Guideline on Good Distribution Practice Products as listed below have been recalled from the market.
Oct 30, 2019 · NPRA's role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall. Recall Classification Class I: A dangerous or defective product that could cause serious health problems or death.
• The scope of this guideline includes information relating to dossier requirements and procedures for submission of endorsement letter application, post-approval changes/variation application for ancillary component, adverse drug reaction and incident reporting for registered combination product.
Under the Control of Drug and Cosmetic Regulatory 1984, NPRA is the only regulatory agency in Malaysia that acts as the secretariat to the Drug Control Authority (DCA).
Jul 12, 2023 · The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guideline on the control of nitrosamine impurities in pharmaceutical products on 3 July 2023. The guideline, based on EMA and FDA guidance, applies to all pharmaceuticals including biologicals which are intended for human use and contain chemically synthesized active ...
The product / cosmetic under NPRA regulatory control status is subjected to changes according to regulatory update / needs. Produk / kosmetik di bawah status kawalan kawal selia NPRA tertakluk kepada perubahan mengikut kemas kini peraturan / keperluan.
The updated guideline for healthcare providers outlines the requirements and procedures of reporting for ADR as well as reporting and investigation of AEFI. It also contains information on the new causality assessment for AEFI.
