DRW Monthly
November 2007
Issue No. 12

EMEA Introduces EudraGMP Database

The European Medicines Agency (EMEA) launched EudraGMP, an online community good manufacturing practice (GMP) database, in May 2007. The goal of the database is to facilitate the exchange of information on compliance with GMPs within the European medicines network. EudraGMP contains information on all manufacturing and importation authorizations issued by the national competent authorities within the EU network including the 25 EU Member States and Iceland, Liechtenstein and Norway. It also includes data on the GMP certificates issued by the competent authorities following each GMP inspection conducted either within the network or in third countries(1). It is hoped that by harmonizing the receipt and recording of manufacturing authorizations and GMP certificates, the network will be better positioned to plan their inspection schedules. In addition, shared access to this data will enable network members to use existing resources more efficiently and will also assist members to avoid duplicating inspections, particularly in third countries.

The development of the EudraGMP database is part of a broader EU telematics strategy in which a number of information technology systems are being designed to facilitate the exchange of pharmaceutical information within the network. Directives 2004/27/EC and 2004/28/EC which amend Directives 2001/83/EC on the Community code relating to medicinal products for human use and 2001/82/EC on the Community code relating to veterinary medicinal products respectively, specifically provide for a database on manufacturing and import authorizations, GMP certificates and non-GMP compliance information.(2) This legislation also authorized EMEA to design and develop the EudraGMP database in close cooperation with the national competent authorities as well as to oversee the implementation of the database.

Unlimited access to the first version of the database is currently only available to national competent authorities, the European Commission and EMEA. The second version, which is hoped to be released by the end of the year, will grant public access to the database. One of the concerns raised about the public access version of the EudraGMP database centers on the limited value of the data for non-network users since they will be restricted to the review of non-confidential documents. Moreover, it is expected that up to 7,000 new GMP certificates will be entered into the database each year (3) which will create a challenge for administrators to keep the data in the system current. In addition, inspections of third countries and any inspections of active substances and certain excipients will increase the number of entries, thereby requiring even more frequent updating of the database. Despite these potential obstacles, industry and government are on the whole extremely pleased by the development of this online resource as it is bringing useful GMP data one step closer to the public as well as improving the ability of network members to share information and harmonize their regulatory activities.

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