21/12/2022
Agreement with the United States on Good Manufacturing Practices for Pharmaceuticals
On 16 December 2022, the Swiss Federal Council approved the Mutual Recognition Agreement between Switzerland and the United States on Good Manufacturing Practices for pharmaceutical products. The agreement aims to facilitate trade in medicines and reduce the administrative burden for industry. It is expected to enter into force in the course of 2023. According to the requirements in Switzerland and the United States, medicines must be manufactured according to internationally agreed rules of good manufacturing practice (GMP). To ensure compliance with these rules, national authorities carry out inspections of manufacturing sites. These inspections are a prerequisite for the marketing authorisation of medicines in many countries, including Switzerland and the United States. In Switzerland, the competent authority is Swissmedic, and in the US, the Food and Drug Administration (FDA).
In the absence of an agreement, manufacturing sites are generally inspected not only by the national authorities but also by the authorities of the importing countries. Thanks to the agreement between Switzerland and the United States, the authority of the importing country will now be able to rely on the inspection carried out by the partner authority. The marketing authorisation of medicinal products will continue to be the subject of an autonomous decision by the competent national authority
