EMEA Launches EudraGMP Database

GMP News
14 May 2007
 

EMEA Launches EudraGMP Database

 
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.


 

Conference Recommendation:

On 24 and 25 May 2007 the EFCG (European Fine Chemical Group), a sector group of the European chemical industry association, will conduct an international conference in Berlin, Germany. Here you will get first hand information from an EMEA Speaker on current developments of the EMEA regarding pharmaceutical APIs . Other authority speakers from the EU Commission and from MHRA and AFSSAPS will provide you with information on GMP for excipients and on GMP inspections and drug counterfeits. You'll find out more at www.efcg-conference.org.

 
Compiled by:
Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)

Source: http://www.emea.europa.eu/pdfs/general/direct/pr/19364007en.pdf

For using the database the EMEA also published a SOP which is available here: http://www.emea.europa.eu/pdfs/technical/sop/SOP8006.pdf
 

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