Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Not There Yet: Concerns Persist On Appropriate Format Of EU GMP Guide For ATMPs

Executive Summary

After holding two rounds of public consultation on its proposals for good manufacturing practice requirements for advanced therapy medicinal products, the European Commission has still not been able to address stakeholder concerns regarding the appropriate format of this eagerly-awaited draft guideline.

You may also be interested in...



EMA Explains When 'Out Of Specification' CAR-Ts Can Be Given To Patients

The European Medicines Agency must be informed about each 'out of specification' batch of a cell or tissue-based advanced therapy that has been granted marketing authorization. The agency warns that if a trend is discovered, it may consider the need for regulatory actions.

Commission Defends GMP Guide For ATMPs As PIC/S Cautions Against Divergence

Regulatory authorities participating in the international Pharmaceutical Inspection Co-operation Scheme are concerned that the European Commission’s proposed good manufacturing practice guideline on advanced therapy medicinal products diverges from PIC/S requirements and will result in lower regulatory standards. The commission defends its approach, saying the guideline will result in high-quality ATMPs and ensure patient protection.

Concerns Over Format Of EU GMP Guideline For ATMPs Finally Resolved; Publication Due

EU biopharmaceutical industry group EBE says it is awaiting keenly the publication of good manufacturing practice guide for advanced therapy medicinal products, after learning that the European Commission is making changes to address concerns it had over the appropriate format of the document.

Related Content

Topics

UsernamePublicRestriction

Register

PS119674

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