Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Why Convergence & Reliance Are Key To Managing The Challenges Of CMC Post-Approval Changes

Executive Summary

Implementing post-approval changes (PACs) is a challenging business. Different countries have their own PAC requirements, approval times and classification systems, which can potentially cause or exacerbate drug supply shortages. In this article, a group of pharmaceutical experts led by Andrew Deavin of GSK tells the Pink Sheet about the concrete progress that is being made to address these problems.

You may also be interested in...



Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’

New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.

International Regulators Address Questions On Leveraging Each Other’s Decisions

Initiatives from regulators around the world seek to promote regulatory reliance at global level.

Regulators Back More Reliance On GMP Inspection Results

As medicines agencies increasingly turn to worksharing and other mechanisms to reduce duplication of effort, the Access Consortium has thrown its weight behind the use of reliance processes for national good manufacturing practice inspection outcomes.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS147293

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