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VOL. 41 | NO. 9 | Friday, March 03, 2017
EU, US to recognize each other's medical site inspections
BRUSSELS (AP) — 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 public health risk."
The accord doesn't affect the process of approving medicines as it focuses solely on inspections of manufacturing sites.