Interpharma welcomes today’s signing of the Sectoral Agreement on Mutual Recognition of Inspection Results between Switzerland and the US (GMP MRA). The agreement, for which Interpharma has been engaging intensively and resolutely over recent years, is an important success for Switzerland as a production hub and for security of supply in Switzerland. This is because the agreement significantly reduces administrative hurdles in trade between Switzerland and the US and will strengthen trade and the resilience of global supply chains. The agreement does not change the current drug approval rules.
After the EU, the US is the second-most important trading partner for research-based pharmaceutical companies in Switzerland: in 2021, its share of total Swiss pharmaceutical product exports (CHF 109 billion) was 26%, with the share of imports (CHF 41 billion) standing at 10%. This makes the sectoral agreement on good manufacturing practices signed by Switzerland in Washington D.C. today an important achievement, for which Interpharma has been engaging intensively and resolutely over recent years. René Buholzer, Managing Director of Interpharma, said:
“Our commitment has paid off. We are very grateful to the Swiss Federal Council for pushing forward with this agreement, which is so important for Switzerland as a production center, and for signing it today. The environment is currently becoming increasingly difficult, which makes this a particularly positive move for Switzerland as a production center.”
The agreement will remove non-tariff trade barriers. This will mean that Switzerland and the US – two countries with high standards of safety and quality – will be able to waive expensive mutual inspections of production facilities in the area of good manufacturing practices. The approval authorities Swissmedic and the American Food and Drug Administration (FDA) will receive the inspection results from their partner and evaluate the quality of the manufacturers’ production systems on this basis. This simplification will not affect the applicable regulatory requirements for the approval of medicinal products in Switzerland and the US.
The agreement makes Switzerland more attractive as a production center and generally improves the conditions for trade between Switzerland and the US. This will strengthen the resilience of supply chains and therefore improve the security of supply. It also creates a level playing field for Switzerland with the EU and the UK in this area, which have already entered into similar agreements with the US. René Buholzer added:
“The sectoral agreement with the US is an important step in enabling Switzerland to remain competitive as a pharmaceutical production center. It will improve the supply of medications and free up resources that can then be used in research and development.”
Interpharma, the association of Switzerland’s research-based pharmaceutical industry, was founded in Basel in 1933.
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