Switzerland is among the top 5 importers of pharmaceuticals in the United States and in 2021, 26% of all Swiss pharmaceutical exports were destined for the U.S. market. To further strengthen the closely integrated U.S. and Swiss pharmaceutical sectors, Swiss State Secretary for Economic Affairs, Helene Budliger Artieda, and Deputy U.S. Trade Representative, Jayme White, signed a Mutual Recognition Agreement on Good Manufacturing Practices for Pharmaceuticals (MRA GMP) on January 12, 2023. This Agreement facilitates the trade of pharmaceutical products between the two countries and substantially reduces the administrative burden on manufacturers.

According to existing regulations, drug manufacturers in both Switzerland and the United States must adhere to internationally agreed GMP rules. While the Swiss Agency for Therapeutic Products Swissmedic (counterpart of the United States Food and Drug Administration FDA) ensures compliance with these rules for drugs produced in Switzerland, the FDA must additionally certify adherence to the same rules if these drugs are to be exported to the United States. This is done by means of cost-intensive and lengthy validation processes at the manufacturing sites. The same process applies for drugs being exported from the United States to Switzerland. With the signing of the MRA GMP, a second inspection of the importing country’s authority will no longer be required in the future, as Swissmedic and the FDA will mutually recognize their respective inspection reports.

The signing of this Agreement is a further milestone in the strong economic relations between Switzerland and the United States across various areas and sectors. State Secretary Budliger Artieda underlined at the signing ceremony in Washington, D.C. that this Agreement will protect jobs in Switzerland as well as in the United States and that it will secure the position of both countries as important pharmaceutical production hubs. Additionally, it will make an important contribution to the public health of both countries by creating a more resilient pharmaceutical supply chain. During the Covid-19 outbreak, fast drug approval processes, reliable supply chains and the mutual recognition of standards have proven to be key success factors in fighting a global pandemic. This Agreement will therefore ensure that the United States can continue to rely on innovative and high-quality Swiss made pharmaceutical products while avoiding lengthy and costly inspection processes.

Following the signing of the Agreement, Swissmedic and the FDA will finalize their assessments of each other’s GMP compliance, which will allow the Agreement to enter into force approximately mid-2023.