FAQ : Reporting by Product Registration Holders

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Reporting by Product Registration Holders (PRH):

1. What are the responsibilities of a PRH in terms of pharmacovigilance activities?

     i) Establishment of an ADR monitoring system
     ii) Submission of spontaneous ADR reports to National Centre for Adverse Drug Reaction Monitoring
     iii) Submission of reports from published scientific literature & post-registration studies
     iv) Evaluation of benefit-risk profile of registered products
     v) Compliance with circulars and directives issued by DCA


2. What is the timeline for submission?

Type of Adverse Event Time Frame for Reporting
Local spontaneous reports:  
Life threatening / fatal As soon as possible but no later than 7 calendar days, followed by as complete a report as possible within 8 additional calendar days
Serious, expected
Serious, unexpected but not life-threatening / fatal
As soon as possible but no later than 15 calendar days
Non serious, unexpected
Non serious, expected
Within 15 calendar days
Foreign spontaneous reports:  
Not required on routine basis  
Local / foreign benefit-risk assessment:  
Notification of changes in nature of severity, frequency or risk factors Within 15 calendar days
New information impacting the risk-benefit profile of product, including international regulatory decisions Within 3 days
Withdrawal of registration in any country Within 24 hours
Periodic safety update reports (PSURs):  
NCE and biotech products 6 monthly for the first 2 years after registration, followed by annually for the subsequent 3 years


3. Is there any guideline available for ADR reporting and monitoring?

     The Malaysian Guidelines for the Reporting & Monitoring is available in NPCB website.


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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