Switzerland now also uses EudraGMDP
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
24.07.2024FDA Warning Letter to a Manufacturer of an Athlete Muscle Maintenance Creme
24.07.2024FDA describes detailed CAPA Procedure in Warning Letter
17.07.2024Congressional Scrutiny on FDA's Foreign Inspection Program puts Pressure on Agency
19.06.2024More FDA Inspections again - also in the EU?
12.06.2024GMP Problems with critical Medicinal Products - what now?
15.05.2024Lack of Quality Oversight: EU Non-Compliance Report issued to Omeprazole Manufacturer