FAQ : ADR Reporting by Healthcare Professionals

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1) What is the scope of ADR Monitoring?
Reporters are encouraged to report any suspicious adverse event, especially on:

- Newly registered drugs

- Reactions encountered with generic products which are not commonly associated with the equivalent market leader product

- Off-label indications

- Doses differing from the recommended doses
2) What should not be reported?
3) What to report?
4) How to report?
5) Basic principles of efficient reporting.
6) Is there any guideline available for ADR reporting and monitoring?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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