- The Food and Drug Administration will now accept results from inspections carried out by drugs regulators in the Czech Republic, Greece, Hungary and Romania, reducing the need for duplicative oversight of manufacturing facilities.
- Recognition of the four countries' agencies expands the number of EU members states that the FDA has said it can rely on to appropriately regulate Good Manufacturing Practices (GMP). Last November, the U.S. agency similarly recognized regulators from eight other countries.
- Under a 1998 agreement, the U.S. and the EU set a goal of mutually recognizing GMP inspections but the annex governing the collaboration was only implemented recently. The two regulators expect the agreement to be operational in all EU countries by July 2019.
Regulatory oversight by the FDA and EU national regulators extends far beyond the borders of each individual country. Agencies from both governmental bodies regularly inspect facilities around the world that manufacture active pharmaceutical ingredients and finished drug products.
Global supply chains and the predominance of India and China in producing drug API, however, means that FDA and EU resources can be stretched thin.
The European Medicines Agency, for example, estimates that about 40% of finished medicines sold within its borders are produced abroad. For nearly nine in ten EU-marketed drugs, one manufacturing step or more occurs overseas.
By mutually relying on each other's inspections, the FDA and EMA can avoid duplicating regulatory work, freeing up resources to prioritize more high-risk sites or other areas of concern.
In June, the European Commission confirmed the FDA's ability to carry out GMP oversight that meets EU standards, allowing member states to use FDA inspections in place of their own.
The FDA's confirmation of each EU member states' capabilities is moving a little more slowly, but the U.S. agency now accepts data from 12 EU national regulators.
Twenty-eight countries are currently part of the EU, although the U.K. is currently in the process of withdrawing from the economic bloc.
As a regulator, the EMA is unique. It draws on the expertise of regulatory authorities in each of the EU member states (plus Iceland, Liechtenstein and Norway). While medicines are approved through the centralized authority of the EMA, inspections can be carried out by individual country regulators.