EMEA launches GMP database
importation certificates and authorisations issued within the
European medicines network has been launched by the European
Medicines Agency (EMEA).
The system has been set up to ease the strain of exchanging vast amounts of information on compliance with good manufacturing practices (GMP) within the European Economic Area. This first version of the database - currently going by the name EudraGMP - will only be available to national competent authorities (i.e. EU member states, Iceland, Liechtenstein and Norway), the European Commission and the EMEA. However, by the summer the system will be available online to the general public free of charge, with only commercially or personally confidential information restricted. The database itself will contain information on all manufacturing and importation authorisations issued by the appropriate agencies within the European network, as well as information on GMP certificates issued by the aforementioned authorities for facilities both within the network and in third countries. Authorities in the member states will have to enter results into the database within 90 days of the completion of an inspection, and manufacturers will also have to submit any certificate changes within a set time period (currently under discussion, but likely to be within 30 days). "The legislative and database requirements introduce a harmonised approach to the receipt and recording of manufacturing authorisations and GMP certificates," says the EMEA. "The facility to exchange inspection related information will assist the EMEA and the member states in planning their inspection schedules." The database will also include information on GMP certificates for excipient manufacture, if and when such regulations are introduced in the EU, in-PharmaTechnologist.com was told. Combine this with information generated following the introduction of GMP requirements for active ingredients and third-country inspections, and the EMEA is justified in expecting that the database will grow rapidly over the coming years. With EMEA estimates putting the number of importers and manufacturers in the countries concerned at around 15,000, with 7,000 or so new GMP certificates added each year, the EudraGMP system is being seen as a mechanism to greatly reduce the duplication of work between national authorities, as well as increasing efficiency and cooperation between the different parties. As well as the impact the database could have on increasing efficiency in information exchange regarding GMP compliance, the EMEA has said that discussions are ongoing with a view to replacing paper certificates used between Mutual Recognition Agreement (MRA) partners. MRA partner countries include Australia, Canada, New Zealand and Switzerland. With the first version of the database already live and accessible by relevant authorities, and the second, publicly accessible version due to come online in the summer, there are two further updates scheduled to be released at later dates to allow the system to expand and accommodate more information. "In the future, the database will include negative as well as positive inspection results," Francisco Penaranda of the EudraGMP development team at the EMEA told in-PharmaTechnologist.com. "So the system will be able to alert member states to non-compliance, as well as making things more transparent to the general public."
