Generics Bulletin 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

Generics Firms Seek To Establish Better Conditions For Post-Approval Change Flexibility

Executive Summary

Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.

You may also be interested in...



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.

Global Post-Approval Changes Outlook Murky As Q12 Lurches Into Consultation

ICH finally proposes a way to resolve the regulatory complexity that has prevented drug makers from establishing and perfecting global approaches to manufacturing their drug products. But with legal concerns persisting in Europe and possibly lurking elsewhere, approval of ICH's draft Q12 guideline could be difficult.

USP Nitrosamine Impurities Chapter Reflects Coordination With EU As Well US Agencies

The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.

Topics

UsernamePublicRestriction

Register

GB151420

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