The Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) have started entering information on good manufacturing practice (GMP) compliance related to Japanese manufacturers, upon the manufacturer’s request, into the EudraGMDP database. This is the first time that information from a non-European regulator has started to be added to EudraGMDP.
The initiative is expected to speed up regulatory processes and save time for importers, manufacturers and regulatory authorities.
This development is part of the mutual recognition agreement (MRA) between the EU and Japan. It allows the EMA, European national competent authorities and Japanese authorities to use information in EudraGMDP instead of issuing original paper GMP certificates for a number of regulatory procedures, such as marketing authorisation applications or variation applications, including the addition of a new manufacturer. The EU and Japanese regulatory authorities will now accept a reference to a EudraGMDP entry, or a downloadable file or print-out from the database, within the scope of the EU-Japan MRA.
The regulatory procedures concerned by these new measures depend on the legal frameworks in Japan and the EU, and they are clarified in relevant notices from the regulators. The EU and Japanese authorities may still request original paper GMP certificates when GMP compliance information cannot be accessed via EudraGMDP.
The EMA offers ‘read and write’ access to EudraGMDP to the regulatory authorities of all countries with which the EU has an MRA or an agreement on conformity assessment and acceptance of industrial products (ACAA). Most of these countries are already using the information in EudraGMDP for their own regulatory procedures; the Japanese authorities are the first to take the initiative to enter data into EudraGMDP.
EudraGMDP is a database operated by the EMA that supports the exchange of information on GMP compliance and non-compliance, as well as on manufacturing and importation authorisations. As of April 2013 it also includes information on good distribution practice (GDP) compliance, as well as registrations of active substance manufacturers, importers and distributors.
Most information in EudraGMDP is publicly accessible, including GMP and GDP certificates. The Agency is planning to make more information accessible in the coming months, including GMP and GDP non-compliance statements.
GMP certificates are issued by regulatory authorities following inspections of manufacturing sites – they certify that a site is GMP compliant.