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...



Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges

Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?

EU Raises Pressure On Pharmaceutical Pollution Of The Environment

Two EU bodies want to move forward with European Commission proposals on contamination of the environment by pharmaceutical substances.

Brazilian Regulator Wins Place On ICH Management Committee

Brazil’s pharmaceutical industry has welcomed the election of medicines regulator ANVISA to the management committee of the International Council for Harmonization.

Related Content

Topics

UsernamePublicRestriction

Register

PS141292

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