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


EU To Defer US GMP Inspections Ahead Of Mutual Recognition Agreement Becoming Operational In November

Executive Summary

EU inspectorates are putting off their plans to undertake any good manufacturing practice inspections in the US wherever possible, in anticipation of the EU-US mutual agreement coming into force in November.

You may also be interested in...

Inspection Data Reveals US/EU Mutual Recognition Agreement's Impact On China and India

The agreement reached in the early days of the Trump administration has been putting China and India drug manufacturing in the crosshairs of the world’s leading pharmaceutical inspectorates.

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.

Related Content





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