Switzerland and USA seek to simplify pharmaceuticals trading

19 December 2022 10:26

CH Business Hub USASwiss Forum Los Angeles

Bern - The Federal Council has given the green light for an agreement with the USA that is set to enter into force in mid-2023. The agreement stipulates that the mutual inspection of drug manufacturing facilities will no longer be necessary. Up to now, this has been a prerequisite for the approval of medicines.

An agreement with the USA on what is known as Good Manufacturing Practice for pharmaceuticals is intended to cut costs and reduce delivery times. The agreement states that both countries will no longer be obligated to inspect each other’s production sites in the future. So far, this has been a prerequisite for the approval of medicines. Instead, the applicable quality standards should be recognized as a matter of principle. The Federal Council, which is the Swiss federal government, approved an agreement of this kind on December 16.

According to a press release jointly issued by the Federal Council, the Federal Department of Economic Affairs, Education and Research (EAER) and the regulatory authority Swissmedic, a corresponding assessment must be completed before the agreement can take effect. It assesses whether the domestic requirements are met by the responsible bodies in the other country. According to the information in the press release, this assessment is expected to be completed by mid-2023.

The press release also emphasizes Switzerland’s economic interest in this agreement with its second most important trading partner in goods. Accordingly, it should support the security of supply and the resilience of the Swiss economy, which is dependent on foreign trade. Agreements of this kind are already in place between the USA and the EU as well as the UK.

The industry association Interpharmawelcomes the approval of this agreement for the sector. As a result, the Swiss pharma industry is “on an equal footing with the EU and the UK”. It also reduces the financial and administrative burden and contributes to the resilience of global supply chains.

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