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Actually the European Medicines Agency (EMEA) had
announced a first version for last year already (as we reported in the
GMP news from 2 October 2006). Now the
EudraGMP database was launched, as the authority informed in a press
release.
The database was developed by the EMEA and authorities of
the EU member states. It contains information on manufacturing and
importation authorisations that were issued by the national EU authorities
and in Iceland, Liechtenstein and Norway. It also comprises information on
GMP certificates granted in member states and third countries. In addition
inspection plans for audits of sites in third countries are supposed to be
available through the database.
EudraGMP is expected to facilitate the information exchange
as well as the national authorities' inspection planning. It will also help
to avoid unnecessary double audits. It is further supposed to improve the
exchange of inspection results in the EU with authorities from outside the
union.
With approximately 15.000 importers and manufacturers in
the relevant countries the database will grow by an estimated 7.000 entries
yearly. Information on inspections in third countries and the future GMP
requirements for APIs will also contribute to a fast growth of EudraGMP.
The EudraGMP database will only be accessible for national
authorities, the EU commission and EMEA.
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