EU, US to recognize each other's medical site inspections

The European Union and the United States have agreed to recognize each other's inspections of facilities where medicines are made.

The 28-nation EU's executive Commission said Friday that it and the U.S. Food and Drug Administration have endorsed an accord that updates a 1998 agreement on manufacturing practices.

It means that EU and U.S. regulators will be able to rely on each other's information on premises that make medicines or their ingredients. The Commission said that this "will improve the EU's ability to identify and address problems at factories before they become a ."

The accord doesn't affect the process of approving medicines as it focuses solely on inspections of manufacturing sites.

Explore further

$580 million EU antitrust fine for drug makers

© 2017 The Associated Press. All rights reserved.

Citation: EU, US to recognize each other's medical site inspections (2017, March 3) retrieved 11 April 2021 from
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Feedback to editors

User comments