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

EMA plans to revise process validation guidance

This article was originally published in The Gold Sheet

Executive Summary

The European Medicines Agency announced plans to revise its process validation guidance, which has been in effect since 2001. The current guide, said EMA, does not reflect the recent regulatory developments affecting pharmaceutical manufacture, such as process analytical technology, quality by design and real-time release testing. These plans were announced in a concept paper published Feb. 25. EMA's Quality Working Group will be developing the guidance, in cooperation with the European Union competent authorities, the EMA PAT Team, and the Biologics Working Party. Pharmaceutical manufacturers and other interested parties are urged to provide input on the forthcoming guide, and have until May 31 to do so

You may also be interested in...



Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK

BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December. 

ESMO: Daiichi's HER3-Targeting ADC Shows Promise, Particularly In Resistant Tumors

HER3 may be a new target for anticancer antibody-drug conjugates; clinical investigators posted promising early stage clinical results with Daiichi Sankyo’s HER3 targeting antibody-drug conjugate, patritumab deruxtecan, at the recent ESMO virtual meeting.

Stockwatch: Can Gilead Wave Its Wand Over Antibody-Drug Conjugates?

After a slow start marked by product withdrawals and toxicity, recent deal-making activity has brought antibody-drug conjugates back from obscurity. But what has changed?

UsernamePublicRestriction

Register

ID1122310

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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