Swiss-US drugs inspection deal comes into force

The medicaments inspection deal does not yet cover vaccines © Keystone / Christian Beutler

The inspection of medicaments is now aligned between Switzerland and the United States, with the aim of saving on paperwork and cost for the pharmaceutical industry.

The Mutual Recognition Agreement (MRA) for inspection of medicinal products came into force on Thursday. The deal allows authorities from both countries to share documents from their routine inspections of pharmaceutical manufacturing facilities, thus erasing duplication of efforts in each country.

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This agreement comes 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.

After the European Union, the US is the second-most important trading partner for research-based pharmaceutical companies in Switzerland. In 2021, the US accounted for 26% of Swiss pharma exports (CHF109 billion) and 10% of imports. 

A similar medicaments MRA between the EU and Switzerland on pharmaceutical products is expected to expire in a few years. But the current political impasse between the two parties.

If the arrangement isn’t renewed, Swiss companies would need to conduct multiple checks and inspections, which could cost the sector an estimated CHF500 million ($558 million) a year in extra costs.