Today, the United States and the EU delivered on an essential element of the Joint Statement agreed by Presidents Trump & Juncker in July 2018. The positive long-haul trade agenda which was established in the Joint Statement is inclusive of a commitment from both sides to bring a reduction in the barriers & increase trade in a variety of sectors, including pharmaceuticals.
The recognition is given to the last outstanding member of the EU, Slovakia by the U.S. Food and Drug Administration, marks the complete implantation of the Mutual Recognition Agreement of the European Union-United States for the production sites for human medicines in their respective territories. This will make the process faster, as well as, less costly for both sides to bring medicines to the market.
The in-charge of Health & Food Safety, Commissioner Vytenis Andriukaitis stated that the completion of the Mutual Recognition Agreement isn’t only a step forward in the trade relations between the European Union and the United States, but it will also ensure high-quality medicines for the benefit of patients. Which means that, on both sides of the Atlantic, the authorities in control of medicines can now count on inspections results to replace their own inspections. The capability assessments of the 28 European Union competent authorities has been completed today by the U.S. Food and Drug Administration, the result of 5 years of close transatlantic cooperation.
This Mutual Recognition Agreement is supported by robust evidence that the U.S. and the EU have comparable procedures to carry out good manufacturing practice inspections for human medicines.
Together, the United States and Europe account for more than 80 percent of the global sales of new medicines. Consequently, complete implementation of this agreement, both the industry, as well as, the public authorities on both sides will be able to free resources which could be utilized to inspect facilities in other large producing countries.