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


FDA, EMA Confidentiality Agreement Expanding Into "Clusters"

Executive Summary

The "chatter" between reviewers and scientists at FDA and the European Medicines Agency appears to be increasing as the two bodies move toward renewing their confidential information sharing agreement

You may also be interested in...

Europe’s EMA And Japan’s PMDA Forge Closer Links On Orphan Drugs

The European Medicines Agency and Japan’s Pharmaceutical and Medical Devices Agency have agreed to share information on the regulatory environment for orphan drugs. The cooperation is aimed at reducing bureaucracy for small- to medium-sized enterprises and improving the authorization process.

“Breakthrough” Designation Another Harmonization Opportunity, Woodcock Says

An agreement with the European Medicines Agency likely would be necessary for therapies designated as breakthroughs to ensure expedited clinical program would be accepted in both jurisdictions.

FDA/EMA/Industry Action On PML Heralds New Foray Into Collaboration

FDA, the European Medicines Agency and the pharmaceutical industry have embarked on a new cooperative effort to develop solutions to drug-related progressive multifocal leukoencephalopathy – a collaboration that could be a springboard for better disease/drug-specific cooperation.

Related Content





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