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

EU, US Commit To Sharing Full Inspection Reports To Supplement GMP Mutual Recognition

Executive Summary

EU and US drug regulators have signed a new confidentiality commitment that allows both parties to exchange full medicine inspection reports with each other. This was not possible before.

You may also be interested in...



US FDA Recognizes Eight EU Authorities, Triggers Mutual Recognition Provisions

US FDA recognizes the drug regulatory authorities for eight of the European Union's 28 member states by a Nov. 1 deadline, triggering key provisions of the landmark mutual recognition agreement.

US Reliance On EU Drug Facility Inspections Begins In November

FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.

EU, US Finally Agree On Mutual Recognition Of GMP Inspections

Reliance on each other’s good manufacturing practice reports should allow EU and US regulators to better focus their limited inspection resources on drug manufacturers in other countries around the world.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121373

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