EudraGMP database

The EudraGMP database is the Community database on manufacturing and import authorisations and good manufacturing practice (GMP) certificates.

The European Medicines Agency launched the system in April 2007, with a second release in July 2009 including GMP non-compliance of manufacturers.

The Agency launched a new version of its EudraGMP database on 7 February 2011, giving the general public access to information on manufacturing inspections performed by regulatory authorities from all European Economic Area (EEA) countries, with the exception of any information of a commercially or personally confidential nature. Previously, limited information coming from only some European countries had been available to the public from July 2009.

The public version of the database is not password-protected.

The public availability of the database enhances openness and transparency. In addition, it aims to:

• improve the sharing of information between regulators and industry;
• aid the co-ordination of activities related to manufacturing authorisations and GMP certificates between regulatory agencies in different European countries;
• eliminate the need for industry to submit applications in paper format;
• facilitate the sharing of information on the outcome of inspections in the European Union (EU) with regulatory authorities elsewhere in the world.

EEA Member States include data in the EudraGMP database as it becomes available. With time, the Agency expects the database to provide information on a total of around 10,000 manufacturers and importers in the EEA, with more than 3,000 new GMP certificates being entered each year. This will be enhanced by information on GMP inspections in countries outside the EU, including inspections of active substances.

Regulatory authorities in the EEA have full read and write access to EudraGMP. The Agency is currently discussing the substitution of the exchange of paper GMP certificates with the partners that it has mutual-recognition agreements with. The Agency expects the database to facilitate the sharing of information on the outcome of EEA inspections with regulatory authorities outside the EEA.

Authorisation and certificate formats, together with relevant procedures, are harmonised and published in the compilation of Community procedures on inspections and exchange of information.

Send any queries regarding EudraGMP functionality to eudragmp@ema.europa.eu.

Press releases on EudraGMP

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