Regulatory News

FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements.

The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug manufacturing inspections worldwide.

“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," FDA Commissioner Scott Gottlieb said in a statement.

Last month, the European Commission also said that FDA can carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. The European Medicines Agency also has mutual recognition agreements with Australia, Canada, Israel, Japan, New Zealand and Switzerland.

In addition to avoiding duplicate inspections, the completion of these capability assessments enables the FDA and the EU to devote more resources to higher-risk manufacturing facilities.

Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy, added: "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."