MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect
Bern, 27.07.2023 - The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in January has entered into force with effect from 27 July 2023. In principle each country thus accepts the inspections carried out by the other’s regulatory authority (Swissmedic or FDA, as the case may be).
The Federal Council already approved the agreement with the USA for mutual recognition of inspections relating to the manufacture of medicinal products on 16 December 2022. On 12 January 2023, this agreement was signed in Washington, D.C. by delegations from Switzerland and the United States. Subsequently, the two partner authorities – the Food and Drug Administration (FDA) and Swissmedic – scrutinised each other’s processes for monitoring medicinal product manufacturers in their respective countries and found them to be comparable.
The MRA guarantees that safe, effective and high-quality medicinal products will continue to be available to patients in both countries while aiming to avoid dual inspections by the FDA and Swissmedic at the same locations.
The State Secretariat for Economic Affairs (SECO) and the Swiss Agency for Therapeutic Products (Swissmedic) welcome the entry into force of this agreement between the two countries. For Swissmedic this signifies a further milestone in its long-standing cooperation with the FDA, notably in the area of GMP (1).
Swissmedic will optimise the implementation together with FDA in the coming months and will work with FDA towards expansion of the scope to vaccines.
In concrete terms the MRA’s entry into force means that, before an inspection is conducted by the FDA in Switzerland or by Swissmedic in the USA, it will be necessary to check whether the production site in question has already been inspected. If so, GMP documents will be made available to the partner authority, subject to consent being given by the manufacturer. These documents can then be used to evaluate the manufacturer instead of conducting an on-site inspection.
(1) GMP, which stands for Good Manufacturing Practices, is a set of internationally applicable rules for the manufacture of pharmaceutical products. Compliance is verified by official inspections and is mandatory for the authorisation of medicinal products in Switzerland and the USA.
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