Swiss-US Pharmaceutical Inspection Agreement Takes Effect

The inspection of medicinal products is now harmonized between Switzerland and the United States, aiming to reduce paperwork and cost for the pharmaceutical industry. The Mutual Recognition Agreement (MRA) for the inspection of medicinal products came into effect on Thursday.

This agreement allows authorities from both countries to share documents from their routine inspections of pharmaceutical manufacturing facilities, thereby eliminating the duplication of efforts in each country. This is particularly beneficial as the complexities of foreign production and sourcing in supply chains for medicine increase, making them more difficult and costly to monitor.

The respective inspection authorities, Swissmedic and the Food and Drug Administration, are working towards extending the inspection alignment to vaccines. The United States is the second-most important trading partner for research-based pharmaceutical companies in Switzerland, after the European Union. In 2021, the US accounted for 26% of Swiss pharma exports (CHF109 billion) and 10% of imports.

A similar MRA between the EU and Switzerland on pharmaceutical products is expected to expire in a few years. The current political impasse between the two parties could lead to the arrangement not being renewed. If this happens, Swiss companies would need to conduct multiple checks and inspections, which could cost the sector an estimated CHF500 million.