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

Differences Put Aside As ICH Finalizes Guide On Post Approval Changes

Final Q12 Document Adopted At Singapore Meeting

Executive Summary

An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.

You may also be interested in...



EU Sees Snags In Implementing ICH Guide On Post-Approval Changes

EU authorities say the new tools and concepts needed for implementing the new international guideline on post-approval changes (ICH Q12) will be considered when the EU framework is reviewed. 

FDA Readies ICH Q12 Implementation Guidance, Learns Lessons From Pilot

Upcoming ICH Q12 implementation guidance will translate terminology on post-approval changes into a US context, said a US FDA official who also shared some lessons learned on established conditions.

Removal Of ‘Legal’ And ‘Implicit’ Terms Cleared Way For ICH Q12 Guideline

Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.

Related Content

Topics

UsernamePublicRestriction

Register

PS141292

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