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Adoption of International Scientific Guidelines in Australia - R02/2024

Adoption of International Scientific Guidelines

Published

TGA has adopted the following 3 international scientific guidelines:

  1. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
  2. Guideline on quality documentation for medicinal products when used with a medical device.
  3. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.

Enquiries

For enquiries relating to the consultation please email isguidelines@health.gov.au.

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