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EMA widens access to EudraGMP database

The European Medicines Agency has increased access to its EudraGMP database, which keeps track of manufacturing inspections from regulatory authorities, to the general public

The European Medicines Agency (EMA) has launched a new version of its EudraGMP database, increasing access to the general public.

The database keeps track of data on all manufacturers of human and animal medicines located in the European Economic Area (EEA) – the EU nations plus Norway, Iceland and Liechtenstein – as well as any information collected by European regulatory authorities about manufacturers from outside the region.

Information contained in the database includes manufacturing and import authorisations and inspections from regulatory authorities, and the registration of Good Manufacturing Practice (GMP) certificates.

The move follows a commitment to greater openness and transparency given by the EMA in December last year, with an initial policy to disclose documents in response to written requests.

Earlier in 2010, the European Parliament had also voted to improve patient access to health and medicines information as part of the EC's 'pharmaceutical package'.

According to the EMA, opening up the EudraGMP in such a way will offer several benefits, including: improving the sharing of information between regulators and industry; eliminating the need for industry to submit applications in paper form; and helping the EMA share information with regulatory authorities elsewhere in the world.

7th February 2011

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