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


ICH Reforms Will "Professionalize" Harmonization, PhRMA's Rep Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Shift in balance of power to regulators is "appropriate" and it's important that the public has trust in ICH, PhRMA Associate VP for Scientific and Regulatory Affairs Patrick Brady says; FDA proposes to contribute $500,000 per year to revised group.

You may also be interested in...

Pharmacovigilance Feeds EMA’s Transparency Drive

The scandal surrounding the withdrawal of Servier’s diabetes drug Mediator (benfluorex) continues to rock the French medical establishment, but it also has drawn attention to the issue of regulators' transparency more broadly – including at the European Medicines Agency.

Proper Venue Sought for Resolving Global Pharma Supply Chain Crisis

Who can coordinate a global response to the pharma supply chain crisis? Industry and regulators debate whether ICH, which smoothed over GMP differences among developed nations, is the right institution for today’s problems, which emanate from non-ICH countries. FDA’s Woodcock describes what the goal should be. IPEC proposes forum to help launch global excipient GMPs. Time is short, with excipient GMPs proliferating in China, Brazil, elsewhere. Support grows for approaching ICH to establish a Q7B guideline for excipients comparable to the Q7A guideline for active ingredients. Big impact expected from Rep. John Dingell’s FDA Globalization Act based on latest discussion draft. Second round of GMP revisions may call for supplier audits, FDA says. IPEC completes excipient qualification guidelines, which set forth process for negotiating quality agreements. The EU advances anti-counterfeiting, regulatory cooperation efforts. Third-party supplier auditing poised for growth.

EU Accelerated Assessment Tracker

Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.


Latest Headlines
See All



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