Malaysia NPRA Updates Requirement of Safety Reporting in Clinical Trial Effective 30 April 2025

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has updated the clinical trial safety reporting requirements in the recently published Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, Edition 8.1.

Key changes include:

1. Non-Malaysian SUSARs: For suspected unexpected serious adverse reactions (SUSARs) occurring at trial sites outside of Malaysia, individual SUSAR reports are no longer required. Instead, it will be replaced by submitting a six-monthly line listing of all such cases to the NPRA.
2. Malaysian SUSARs: The reporting requirements for SUSARs arising from trial sites within Malaysia remain unchanged.
3. Vaccine Trials – AEFI and AESI Reporting: The guideline has included the requirement to report serious Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) in vaccine clinical trials.
4. Development Safety Update Report (DSUR): Submission of the DSUR is now mandatory.

 

For more information, please refer to

https://www.npra.gov.my/easyarticles/images/users/1145/20250327-Malaysian-Guideline-for-Application-of-CTIL-and-CTX-8.1-ISBN.pdf

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