EU and Japan improve information-sharing using EudraGMDP database

Information will be shared between Japan and the European Union about good practice compliance relating to Japanese pharmaceutical manufacturers, the European Medicines Agency has announced.

The Japanese Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) have started entering information on Good Manufacturing Practice (GMP) compliance related to Japanese manufacturers into the EudraGMDP database, which is operated by the EMA to support the exchange of information on GMP compliance and non-compliance, as well as on manufacturing and importation authorizations.

This is the first time that information from a non-European regulator has started to be added to EudraGMDP and the initiative is expected to speed up regulatory processes and save time for importers, manufacturers and regulatory authorities.