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.
