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

EMA To Establish Minimum Requirements For CAR-T Cell Registries

Executive Summary

The European Medicines Agency is exploring the possibility of establishing minimum requirements for all CAR-T Cell registries in the EU to facilitate efficient data collection on such products in the post-authorization phase.

You may also be interested in...



EMA Defines Actions For Using CAR-T Registries For Regulatory Evaluation

A multi-stakeholder EU workshop has helped identify how patient registries can support the benefit-risk evaluation of CAR-T cell therapies, given the challenges posed by these products, not least the need for the long-term follow up of treated patients.

EMA To Improve Dialogue With Registry Holders To Support Drug Evaluation

The European Medicines Agency is looking at ways to promote the systematic use of patient registries to support the evaluation of the benefits and risks of medicines.

Global Pharma Guidance Tracker – March 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122149

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