NPRA released the updated Serious Breach Report (Regulation: N3-FR-82, Regulation ID: INS200852) for medicinal products.
The document outlines mandatory reporting procedures for serious breaches in clinical trials. It covers submission guidelines (to mygcp@npra.gov.my), trial information, general details, breach description, actions taken/CAPA, and CTIL/CTX Holder declaration. Version dated Dec 2025, 4 pages.
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