Pharmacovigilance

NPRA strives to ensure the safety of medicinal products through pharmacovigilance. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.[1]

 

Among the pharmacovigilance activities carried out by NPRA are adverse drug reaction (ADR) monitoring and screening of drug safety alerts. These activities allow identification of drug safety issues, which are reviewed in order to implement preventative measures. NPRA also communicates information on drug safety issues to healthcare professionals and the public, in our ongoing effort increase patient safety.

 

Reference1. WHO (2002). The Importance of Pharmacovigilance: Safety monitoring of medicinal products. pp 7-81. WHO (2002). The Importance of Pharmacovigilance: Safety monitoring of medicinal products. pp 7-8

Recent Updates, Directives & Circulars


  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Pharmacovigilance
  • Directives & Circulars Related to Pharmacovigilance
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National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 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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