Switzerland: Implementation of the MRA for the GMP of Medicinal Products (27 July 2023)

ARQon
Sep 12, 2023
1 min read

United States (FDA) and Switzerland (Swissmedic) were mutually recognized as regulatory authorities for each country, effectively enforced from 27 July 2023, through the Mutual Recognition Agreement (MRA), signed in January 2023.

The MRA was signed after the FDA and Swissmedic had carefully scrutinized each other’s monitoring procedures for manufacturing medicinal products and found them to be comparable.

On-site inspection for medicinal manufacturing shall be done so the GMP certification acquired by the manufacturers can be made available to the partner authority. The GMP certification will be used to evaluate the manufacturer.

The accreditation marks a significant turning point in Swissmedic's long-term partnership with the FDA. Besides, MRA also assures effective, safe, and high-quality medicinal products will be continuously available for patients from both USA and Switzerland.

Source: Swissmedic