Switzerland now also uses EudraGMDP
Recommendation
26/27 June 2025
Barcelona, Spain
Supervision of the Pharmaceutical Supply Chain: Challenges and Opportunities
Register now for ECA's GMP Newsletter
An agreement between the EU and Switzerland on the mutual recognition of conformity assessments (MRA = Mutual Recognition Agreement) has been existing for years. This MRA covers various areas, including medical devices and medicinal products. Adjustments were made in summer 2017.
One goal was to strengthen the exchange of information. Switzerland was to be given access to the EudraGMDP. This GMP database, managed by the European Medicines Agency (EMA), is intended to contain authorisations, GMP certificates and information on non-compliance with GMP principles from all contracting parties in a format conforming to the procedures published by the EU.
Swissmedic has now begun to enter information on GMP inspections and manufacturing authorisations for Swiss manufacturers into the database. This applies to all new or renewed authorisations and the associated GMP certificates.
Source: EMA Press Release
Related GMP News
18.06.2025FDA Warning Letter with Supplier Qualification Observations
11.06.2025Root Cause Investigations criticised at EU Company
21.05.2025More FDA Warning Letters citing Quality Oversight
21.05.2025New Version of GMP Auditors Handbook available
21.05.2025FDA: more unannounced Inspections also outside the US