Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124944

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel