Malta Recognised By The FDA As Capable Of Conducting Inspections Of Its Manufacturing Facilities

 The FDA oversees drug manufacturing by routinely inspecting domestic and foreign drug manufacturing plants for compliance with manufacturing standards that assure quality and product label requirements.

Malta is among eight European countries determined by the US Food and Drug Administration (FDA) as capable of conducting inspections of manufacturing facilities that meet FDA requirements.

The seven other regulatory authorities found to be capable are those located in Austria, Croatia, France, Italy, Spain, Sweden and the United Kingdom.

Some drugs approved in the US are either fully manufactured overseas or made in the US but contain some foreign ingredients. All drugs approved in the US, regardless of where they are made, must comply with applicable US regulations. One way the FDA oversees drug manufacturing is by routinely inspecting domestic and foreign drug manufacturing plants for compliance with manufacturing standards that assure quality and product label requirements.

“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, M.D.

“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.”

“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.”

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