Australia Consults On Adopting EU Extrapolation Paper And Other Guidelines
Executive Summary
The Australian regulator has proposed adopting several European Medicines Agency guidelines. For some of these guidelines, the Therapeutic Goods Administration has added its annotations.
You may also be interested in...
Australia Explains New Guidance on Risk Management Plans
Australia has revamped its guidance on the new and updated risk management plans to clarify what is expected of manufacturers when developing and submitting RMPs for different kinds of products.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.