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

ICH Q12 Experts Develop Four-Tier Scheme For Harmonizing Post-Approval Changes

Executive Summary

Ambitious effort to enable fuller, quicker rollout of post-approval manufacturing changes progressed at ICH meeting in Lisbon, participants told recent conferences. Much of the focus of ICH Q12 discussion was on harmonized reporting categories so manufacturers could make more changes before obtaining approval – and in some cases without even seeking approval.

You may also be interested in...



‘Critical’ Issues Need Resolution Before ICH Q12 Proceeds To Next Step

Industry and regulatory working group participants are grappling with established conditions and post-approval change management protocols in developing early ICH Q12 draft guidance. Latest proposal calls for three post-approval change categories.

Quality Regulatory Updates In Brief: ICH, EMA, MHRA and FDA

ICH updates progress made on quality guidelines; EMA talks combination products; UK MHRA report sheds light on GMP deficiencies; MHRA official describes compliance escalation; FDA guides microbiology reviewers through Common Technical Document; FDA OKs reliance on non-USP compendia in applications.

FDA Encourages 'Established Conditions' Use Despite ICH Q12 Uncertainty

Go ahead and list the 'established conditions' in your NDAs, ANDAs and BLAs that require regulatory notification in the event of post-approval changes, which leaves all other CMC changes to be managed internally, FDA tells industry. But the agency wants a heads up if you're planning to do that, as the 'established conditions' paradigm continues to evolve in the context of ICH Q12 deliberations.

Related Content

Topics

UsernamePublicRestriction

Register

OM007016

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