FAQ : Clinical Trials – Safety Reporting

1. Is Serious Adverse Event (SAE) report required to be submitted to NPRA?
SAE reporting is NOT required but SUSAR reporting to NPRA is mandatory.

In case of SAE reporting, the report should be submitted to the respective Ethics Committee depending on their requirements. We encourage you to check with the individual Ethics Committee to find out their reporting requirements.
2. What are the criteria for the reporting of Suspected Unexpected Serious Adverse Reaction (“SUSAR”) to NPRA?
3. What is Adverse Drug Reaction (ADR)?
4. What is “Serious” Adverse Drug Reaction?
5. What is “Unexpected” Adverse Drug Reaction?
6. Is SUSAR related to comparator or placebo NOT required for submission to NPRA?
7. When should we start and end SUSAR reporting for the clinical trial conducted in Malaysia?
8. How to report SUSAR to NPRA?
9. What is the minimum information required for expedited reporting purposes?
10. What should I do if I do not receive Acknowledgement of Receipt (AoR) for the submitted SUSAR reports which contain the minimum information?
11. What is the timeline for SUSAR reporting?
12. Is the timeline of SUSAR reporting counted from “Date Received by Manufacturer” or “Date of SUSAR Report” of a SUSAR report in CIOMS-I format?
13. Do we need to open/break the code (unblinding) prior to sending SUSAR reports to NPRA?
14. Is it a MUST to report SUSAR in a secure mail?
15. Is there any requirement set forth by NPRA on SUSAR reporting to investigator?
16. In Malaysia, there are two clinical trials (Trial A and B) investigating the same drug/product. The CTIL/CTX holders for these two trials are from two different companies, i.e. Company C for Trial A and Company D for Trial B. If a SUSAR has arisen from Trial A, NPRA would like to receive this expedited report from company C only (as direct report) or both companies (additional cross report from company D)?
17. In Compassionate Use Programme, a named patient is given a privilege to have an early access to an unregistered product in Malaysia. Any SUSAR arisen from the programme should be reported to Centre for Investigational New Product or Centre for Post Registration?
18. Should the SUSAR arisen from the following named patient programme be reported to Centre for Investigational New Product or Centre for Post Registration?
19. Is it necessary to submit the following documents to NPRA?
20. Is there any guideline on safety reporting in clinical trial?
21. Who should I refer to if I have any further queries on safety reporting in clinical trial?

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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