Notícias

FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections

November 17, 2017

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.

This achievement marks an important milestone to successful implementation and operationalization of the amended Pharmaceutical Annex to the 1998 U.S. - European Union (EU) Mutual Recognition Agreement (MRA) that enables U.S. and EU regulators to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

“Beginning November 1, we will take the unprecedented and significant step forward in realizing the key benefits of the Mutual Recognition Agreement with our European counterparts in that we will now rely on the inspectional data obtained by these eight regulatory agencies”, said Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy. “The progress made so far puts us on track to meet our goal of completing all 28 capability assessments in the EU by July 2019.”

 

EMA 

FDA 

Get more information by clicking here:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583057.htm