EudraGMP
Encyclopedia
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice
. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general public, via Internet, is available since 2009 using the URL : http://eudragmp.ema.europa.eu.
EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission
, the European Medicines Agency
and the Member State competent authorities.
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general public, via Internet, is available since 2009 using the URL : http://eudragmp.ema.europa.eu.
EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
, the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
and the Member State competent authorities.
See also
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- EudraCTEudraCTEudraCT is the European Clinical Trials Database of all clinical trials commencing in the European Union from 1 May 2004 onwards...
- EudraPharmEudraPharmEudraPharm is the database of medicinal products authorised in the European Union, and includes the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
- GxPGxPGxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries....