Pharmacovigilance

TGA – Pharmacovigilance obligations of medicine sponsors

The TGA has published answers to FAQ’s relating to the pharmacovigilance obligations of sponsors of medicines on the ARTG. The aim is to support understanding of the pharmacovigilance responsibilities of medicine sponsors. The following topics are covered in the FAQ:

  • Collecting and reporting adverse drug reactions.
  • Post-registration studies and post-marketing initiatives.
  • Searching Australian and worldwide medical literature.
  • Identifying and reporting significant safety issues.
  • Updating Australian Product Information (PI) and Consumer Medicines Information (CMI) documents.
  • Australian pharmacovigilance contact person and Qualified Person for Pharmacovigilance in Australia (QPPVA).

Refer below links for more details:

https://www.tga.gov.au/pharmacovigilance-obligations-medicine-sponsors

https://www.tga.gov.au/book/export/html/763772

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2 responses to “TGA – Pharmacovigilance obligations of medicine sponsors”

  1. Porus Rajpurohit Avatar
    Porus Rajpurohit

    One of the Interesting topic I would suggest you that is- Info on Argus Safety Data Base (Basics and data entry at least). it will help the freshers a lot. I have seen someone doing it on LinkedIn.
    Thanks. Keep up keep up the good work.

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    1. Ramya Avatar
      Ramya

      Thank you. I appreciate the positive feedback. We are planning to create free course on Basic details of Argus safety database as it is one of the most requested topic.

      Reply

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