New version of EudraGMP allows access to information from all Member States

News 08/02/2011

The European Medicines Agency has launched a new version of its EudraGMP database giving the general public access to information on manufacturing inspections performed by regulatory authorities from all European Economic Area (EEA) countries.

EudraGMP, which was first launched in May 2007, contains information on all manufacturers of human and veterinary medicines located in the EEA, and other manufacturers outside the EEA that have been inspected by European regulatory authorities. It includes details of the manufacturers' manufacturing and importation authorisations and good-manufacturing-practice (GMP) certificates.

The latest version of the database allows public access to the authorisation and GMP certificates coming from all countries in the EEA, including all European Union (EU) Member States plus Iceland, Liechtenstein and Norway. Previously, limited information coming from only some European countries was available to the public.

This initiative, which is part of the Agency's drive towards a greater level of openness and transparency, will:

  • 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 form;
  • facilitate the sharing of information on the outcome of inspections in the EU with regulatory authorities elsewhere in the world.

The information in the database is continually updated by European regulatory authorities: the Agency expects around 3,000 new certificates to be imported into EudraGMP every year. It also expects the database to grow rapidly over the next few years, following the introduction of inspections in countries outside the EU and new GMP requirements for active substances.

Users of the database should note that European legislation does not require routine GMP inspections for all manufacturers of active substances, so the absence of a certificate for a particular manufacturer does not mean that it does not comply with GMP rules. In addition, the database restricts access to information of a commercially or personally confidential nature.

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