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 'Completely Reworks' Parts Of Gene Therapy Products Guideline

Executive Summary

The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy medicinal products based on stakeholder feedback and to address issues in light of the experience gained with these products.

You may also be interested in...



Familiar Principles In Gene Therapy Guidance For Rare Diseases

Use of historical controls and alternative study designs are allowed, but randomized control trial is preferred.

EMA Close To Finalizing Gene Therapy Products Guidance; No Scope For Further Approximation To International Norms

The European Medicines Agency says there is no scope to harmonize further its guidance on gene therapy medicinal products with international norms as the main focus of the document is on fulfilling data requirements to support an EU marketing authorization application.

WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency

The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123506

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