Malaysian Pharmacovigilance Guidelines 2nd Edition

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Second Edition

  • The Malaysian Guidelines for the Reporting & Monitoring 2002 has been updated to align with current international requirements in adverse drug reaction (ADR) reporting and safety monitoring for medicinal products.
  • In addition, this guideline has been updated to explain in detail on ADR reporting for Healthcare Professionals and Product Registration Holders.
  • This guideline will be implemented with immediate effect.

(Refer letter to Product Registration Holders, Ruj.Kami: (73)dlm.BPFK/17/FV/4 JILID51, Date: 5 September 2016)



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


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Sabtu 21 September 2019, 10:25:58.
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