FDA, European Regulators Align for More Efficient GMP Inspections

The US greenlights eight international agencies to audit facilities.

Offering further evidence of the implementation and operationalization of the amended Pharmaceutical Annex to the 1998 US/European Union Mutual Recognition Agreement (MRA), as well as the globalization of the industry, the FDA announced that it will recognize eight European drug-regulating agencies as “capable of conducting inspections of manufacturing facilities that meet FDA requirements.”

Federal drug regulators said that in the wake of capability assessments, Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom are now certified to conduct GMP-level inspections of pharmaceutical manufacturing facilities on behalf of the FDA in their respective jurisdictions.

Regulators explained the achievement marks an important milestone in the implementation of the MRA Pharmaceutical Annex. “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. “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.”

Some drugs approved in the US, said the FDA announcement, are either fully manufactured in other countries or made from ingredients and active pharmaceutical ingredients outside US borders. According to FDA all drugs approved in this country, regardless of origin, must comply with all applicable US regulations. The way the agency accomplishes that, it said, is by conducting inspections.

Dara Corrigan, the FDA’s Acting Deputy Commissioner for Global Regulatory Operations and Policy noted that “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. 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.”

 

Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College.