##  [Malaysia NPRA Updates Compliance Requirements for Serious Breach Reporting](/index%2Ephp/mandate/malaysia-npra-updates-compliance-requirements-for-serious-breach-reporting) 

December 1, 2025

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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Source

[https://npra.gov.my/easyarticles/images/users/1140/N3-FR-82-Serious-Breach-Repo…](https://npra.gov.my/easyarticles/images/users/1140/N3-FR-82-Serious-Breach-Report.pdf)

 

 

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