Switzerland has reached a mutual recognition agreement with the US for GMP inspections

Sandra Ragaz-Fumia
Leader Pharma & Life Science Consulting for Regulatory & Indirect tax,  PwC Switzerland

Switzerland has reached a Mutual Recognition Agreement (MRA) with the United States for good manufacturing practice (GMP) inspections, which will facilitate and decrease administrative barriers in the exchange of pharmaceutical products between the two countries, which will further strengthen the supply chain.

Management summary

  • Switzerland has signed an MRA with the US for GMP inspections, which will help to reduce costs for inspections and streamline the regulatory process for pharmaceutical products. 
  • The MRA allows Swiss manufacturers to rely on US inspections of their facilities and vice versa.
  • In particular, the US and Swiss authorities will receive the results of the inspections conducted by the local authority and assess the quality of the manufacturing process based on the results of the inspection and will waive inspections of drug manufacturing sites in each other's country.

Additional information

  • The MRA was negotiated by Swissmedic, the Bureau of the United States Trade Representative (USTR), Swissmedic and FDA.
  • The MRA was approved by the Federal Council on 16 December 2022. The agreement was signed by both parties in Washington on 12 January 2023.
  • Switzerland now has a similar agreement with the United States like the US does with the EU and the United Kingdom. As a consequence, the agreement also strengthens Switzerland's position as a global hub for the pharmaceutical industry and helps build resilience of the supply chain.
  • The MRA is expected to lead to increased trade in pharmaceutical products between Switzerland and the US, which is already one of Switzerland's largest trading partners.
  • The current regulatory requirements for drug approval in Switzerland and the USA remain unaffected by this simplification.
  • Switzerland still does not have a respective MRA with the European Union after the stop of negotiations with the European Commission for the bilateral agreements.  

What does it mean for you?

  • Swiss pharmaceutical manufacturers will benefit from streamlined regulatory processes and reduced costs when exporting their products to the US and vice versa.
  • Consumers in both countries may benefit from increased access to a wider range of pharmaceutical products.
  • It is important for a pharmaceutical company to adhere to regulatory standards for Good Manufacturing Practices (GMP) in both Switzerland and the US, which is crucial to safeguarding the supply chain and minimising additional expenses.

How the MRA can be leveraged for sustained growth and increased profitability 

  • Diversification of the supply chain: Manufacturing sites in different countries will help a pharmaceutical company to diversify and protect its supply chain and as a consequence reduce the risk of disruptions (e.g. natural disasters, trade disputes).
  • Access to local talent: Switzerland and the United States have highly skilled and educated workforces. A pharmaceutical company can gain access to expertise in various areas, which can accelerate product development or improve its operations (e.g. tax structure).
  • Innovation and collaboration: By having operations in leading pharma & life science crossroads, pharmaceutical companies can tap into local innovation hubs and collaborate with research organisations, academic institutions and foster collaboration with other pharmaceutical companies to accelerate innovation and deliver better patient outcomes.
  • Improved cost structure: By having operations in different regions, a pharmaceutical company can take advantage of regional cost differences and optimise its cost and tax structure.

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Contact us

Dr Sandra Ragaz-Fumia

Dr Sandra Ragaz-Fumia

Partner, Leader Pharma & Life Science – International Indirect Tax & ReguIatory, PwC Switzerland

Tel: +41 58 792 44 69

Dominik Hofstetter

Dominik Hofstetter

Senior Associate, Pharma & Life Science Regulatory, PwC Switzerland

Tel: +41 58 792 49 05