The US Food and Drug Administration (FDA) has announced its decision to recognize the capability of eight regulatory authorities in Europe, which it states will lead to greater efficiency in ensuring the safety of medicines and pharmacy products.
Inspections of manufacturing facilities by regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom will now be accepted by the FDA. It described the decision as an "important milestone" in implementing the amended Pharmaceutical Annex to the 1998 US-European Union Mutual Recognition Agreement.
For a drug to appear in local pharmacies in the US it must comply with all applicable American regulations, regardless of where it is manufactured, laws that also apply to any ingredients used in the medication. The FDA regularly inspects domestic and overseas manufacturing plants to ensure they comply with US regulations and meet the labeling and quality requirements.
The Mutual Recognition Agreement enables regulators in the United States and Europe to make use of each other's inspections of good pharmaceutical manufacturing practice, a move which FDA Commissioner Scott Gottlieb, MD, said will help "maximize global resources while realizing the greatest bang for our collective inspectional buck".
"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," he added.
The latest move by the FDA is expected to streamline inspection processes and cut out duplicate inspections by regulatory bodies in Europe and the United States. A further benefit is that it will liberate time and resources to conduct more inspections in countries where there is a greater risk of lower manufacturing standards.
Under the Mutual Recognition Agreement, the FDA will inspect the regulatory authorities of all EU countries individually to ensure standards are equivalent to those in the United States. Dara Corrigan, acting deputy commissioner for global regulatory operations and policy, stated: "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."
Europe already has its own Mutual Recognition Procedure in which manufacturers apply for marketing authorization in one EU state, which does an assessment of the application. This report is then reviewed by other states in which the company wants to release the drug. If there are no serious objections, the drug is granted approval for use in these countries.
