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Mar 05

Swissmedic & the European Medicines Agency Confirm New Mutual Recognition Agreement

The EudraGMDP database, operated and maintained by the European Medicines Agency (EMA), contains useful information about the Good Manufacturing Practice (GMP) and Good Distribution Certificates (GDP) of active substances for human use located in the European Economic Area (EEA). This includes statements of non-compliance with GMP and GDP, as well as the registration data of all manufacturers, importers and distributors of these products within the EEA. Almost everything uploaded onto the database can be accessed by the general public in read-only mode; however National Competent Authorities (NCAs) do have the power to limit access to sensitive information.

All EEA Member States and countries that have a Mutual Recognition Agreement (MRA) with the EU are offered “read and write” access to the EudraGMDP database. As of 2019, the EU has MRAs with Australia, Canada, Israel, Japan, New Zealand, the United States, and now Switzerland.

As part of this Mutual Recognition Agreement (MRA) between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has now started to input their GMP inspection data into the EudraGMDP database. This means that GMP certificates issued by EU or Swiss authorities, previously distributed in paper form, may now be replaced with a downloadable EudraGMDP file. This will hope to improve the efficiency of information-sharing between stakeholders of the European Medicines Agency (EMA).

For more information on the EudraGMDP database, as well as how the MRA between the EMA and Swissmedic aims to improve communication between both parties, please visit the EMA website.

*Source: FDA News

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