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


Why Industry Says Global Post-Approval Complexity Must Change

Executive Summary

Post-approval nightmares shared in biopharmaceutical CMC strategy session. One firm's 'impossible' task: making a drug 55 different ways for 105 countries.

You may also be interested in...

How Inspectorates Will Judge Quality Systems' Ability To Manage Manufacturing Changes

PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.

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.

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

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.





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