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 To Bring Complex Stem Cell Therapies Within Regulatory Fold

Executive Summary

Taking cue from the regulators in the US and the EU, the Australian government is developing a policy to formally regulate the increasingly complex field of stem cell therapies. The new regulatory approach is to be supported by detailed guidance from the Therapeutic Goods Administration to help legitimate products gain approval.

You may also be interested in...



Australia Clarifies Regulatory Oversight Of Human Tissues And Cell Products

New rules on the regulation of autologous human cell and tissue products have been introduced in Australia, together with clearer definitions of biological products.

US FDA's Drug Seizures Seen As Most Significant Aspect Of Stem Cell Crackdown

Former Office of Compliance and Biologics Quality Deputy Director Mark Schwartz says dishonest players have not often seen serious enforcement actions from the agency.

Global Medtech Guidance Tracker: February 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121834

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