FDA to Recognize Facilities Inspections by 8 European Regulators

The FDA has announced that the agency will recognize 8 European regulatory agencies as capable of conducing manufacturing facilities inspections that will meet FDA requirements. The agencies named are those of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom.
The Center for Biosimilars Staff
November 01, 2017
The FDA has announced that the agency will recognize 8 European regulatory agencies as capable of conducting manufacturing facilities inspections that will meet FDA requirements. The agencies named are those of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom (though the FDA’s announcement did not indicate whether recognition for the United Kingdom would remain in force after the nation withdraws from the European Union).

The announcement marks a key step in implementing the United States and European Union’s Mutual Recognition Agreement that allows US and EU regulators to use one another’s good manufacturing practice (GMP) inspections of manufacturing facilities, and follows a June 2017 announcement by the European Commission that the FDA has the capacity to carry out GMP inspections at a level equivalent to EU inspections.

“At a time in which medical product manufacturing is truly a global enterprise, there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck,” said FDA commissioner Scott Gottlieb, MD. “By partnering with these countries we can create greater efficiencies and better fulfill our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries.”

Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy, said that the agency is on track to complete assessments of inspection capability for all 28 EU member states by July 2019. The European Union also already holds mutual recognition frameworks with other international regulators, including those located in Australia, New Zealand, Canada, Japan, and Switzerland.

In August, the FDA made a first step toward greater regulatory cooperation with the European Union when it signed a confidentiality agreement with the European Medicines Agency (EMA) and the European Commission (EC) that allows the FDA to share full inspection reports with both European bodies. While the FDA had previously maintained confidentiality agreements with the EMA and EC since 2003, prior arrangements had not included the ability to share full reports, inclusive of commercially confidential information, including trade secrets.

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