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London (May 1)-The European Medicines Agency launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices.
London (May 1)-The European Medicines Agency (EMEA, www.emea.europa.eu) launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices (GMPs).
EMEA designed and launched the database, called EudraGMP, to improve national competent authorities’ ability to supervise the quality of medicines. It contains information about all manufacturing and importation authorizations issued by national authorities of individual European Union (EU) member states as well as Liechtenstein and Norway. The database also contains information about GMP certificates, which the competent authorities issue following each GMP inspection conducted either within the network or in third countries.
EMEA expects that EudraGMP will improve the sharing of information and the coordination of action for manufacturing authorizations and GMP certificates between national authorities by eliminating duplication. The database also facilitates the sharing of information about the outcome of EU inspections with regulatory authorities outside Europe.
Only national competent authorities, the European Commission, and EMEA can access the database. National competent authorities worked closely with EMEA to design the database as part of the EU telematics strategy for pharmaceuticals. The strategy was agreed upon by EU member states, the European Commission, and EMEA in 2000.
Approximately 15,000 importers and manufacturers operate in Europe, and EMEA expects that as many as 7000 potential new GMP certificates will be included in the database each year. These numbers are expected to increase as third-country inspections begin and new GMP requirements for active substances are implemented.