US widens recognition of EU drug plant inspections
- The Food and Drug Administration this month recognized the capabilities of health authorities from five more European Union member states, deepening regulatory ties under an international deal aimed at improving global inspections of pharmaceutical manufacturing.
- Inspections conducted by agencies from Belgium, Denmark, Finland, Latvia and Estonia will now be recognized by the FDA. These additions, first reported by Regulatory Focus, mean drug inspections by the U.S. and 20 EU member states are now mutually recognized.
- The European Medicines Agency confirmed it will still batch-test imported drugs and active pharmaceutical ingredients itself until the FDA recognizes the capabilities of all member authorities. For its part, the FDA will assess expansion of the agreement to cover veterinary medicines by July 2019 and vaccines for human use and plasma-derived medicines by July 2022.
As drug development and manufacturing has become increasingly globalized, regulators in the U.S and Europe have made collaboration a priority.
Regardless of whether drugs are produced in India or in Ireland, regulatory authorities still need to ensure products and the plants that make them meet international standards for safety and potency. That tall task can fall heavily on the shoulders of individual regulatory authorities, which have limited resources for inspection.
Mutual recognition agreements allow regulatory authorities to rely on one another's inspection of GMP facilities. These increase efficiency for both the U.S. and EU regulatory systems by reducing the number of duplicated inspections, as well as enabling reallocation of resources toward inspecting higher-risk drug manufacturing facilities worldwide.
Europe and the U.S. signed an agreement in March 2017 to recognize one another's drug manufacturing inspections, which came into force in November 2017.
The FDA has recognized 20 different authorities so far, and expects to complete the capability assessment of all of the EU inspectorates by July of next year.
In June 2017, the European Commission confirmed that FDA has the "capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU."
- BioPharma Dive FDA recognizes GMP inspections by 4 more EU states
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