TGA adopts new international scientific guidelines

TGA adopts new international scientific guidelines

09 Sep 2025

The Therapeutic Goods Administration (TGA) has adopted three important international scientific guidelines to strengthen the regulation of medicines and medical devices in Australia.

The newly adopted guidelines are:

  1. ICH E9 (R1) Addendum – Covers estimands and sensitivity analysis in clinical trials, complementing the guideline on statistical principles for clinical trials.

  2. Quality Documentation Guideline – Provides guidance on documentation for medicinal products used with medical devices.

  3. Good Pharmacovigilance Practices (GVP) Module I – Focuses on pharmacovigilance systems and their quality standards.

These guidelines help ensure clinical trials, medical products, and safety monitoring meet high international standards.

For questions about the guidelines, contact isguidelines@health.gov.au.

Source: Therapeutic Goods Administration (TGA)

 
 

Categories

Popular Posts

Tags