Switzerland and USA implement mutual recognition agreement to streamline pharmaceutical trade
Business environment
31 July 2023
This agreement will ease trade of medicines with the United States and reduce the administrative burden for the industry.
A Mutual Recognition Agreement (MRA) between Switzerland and the United States concerning Good Manufacturing Practices (GMP) for pharmaceutical products has come into effect.
The Swiss State Secretariat for Economic Affairs (SECO) and Swissmedic, the Swiss Institute of Therapeutic Products, welcome the enforcement of the agreement between Switzerland and the United States regarding mutual recognition of GMP for pharmaceutical products. Signed on 12 January 2023, in Washington DC, the agreement required a mutual evaluation of authorities’ operations before coming into effect. This evaluation between Swissmedic in Switzerland and the Food and Drug Administration (FDA) in the United States has been concluded positively.
In both Switzerland and the United States, drugs must be manufactured according to international GMP rules. Pharmaceutical manufacturers’ production sites are therefore regularly inspected by competent authorities, a prerequisite for market authorization of drugs. Thanks to the agreement, starting from 27 July 2023, Swissmedic and the American FDA will utilize inspection reports from the partnering authority for their evaluation. This process, in principle, prevents duplicate inspections of production sites, saving significant human and financial resources. This simplification does not affect the requirements for market authorization of drugs in Switzerland and the United States, which will always be a standalone decision by the respective national authority.
Bolstering pharmaceutical trade and supply security
This MRA on GMP recognition should enable pharmaceutical companies in both countries to reduce costs and delivery times. It will also contribute to strengthening the production and distribution chains between Switzerland and the United States, thus enhancing Switzerland’s pharmaceutical supply security. Simultaneously, the agreement levels the Swiss pharmaceutical industry with the EU and the United Kingdom, which have similar agreements with the United States.
The United States is Switzerland’s second-largest trading partner in the pharmaceutical sector. In 2022, Switzerland exported drugs to the United States worth approximately CHF 29 billion, while it imported drugs from the United States worth around CHF 5 billion.
Switzerland has similar agreements with the EU, the United Kingdom, Canada, and South Korea.
