EMA Adds Statements of GMP Non-Compliance to EudraGMDP

Jan 08, 2014
By PharmTech Editors

The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database, which includes, among other changes, the publication of statements of non-compliance with good manufacturing practice (GMP). These non-compliance documents, as well as positive GMP certificates, are now publicly accessible, EMA reports.

Statements of non-compliance contain information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health. These statements aim to establish a coordinated and harmonized response by the network of European Union (EU) medicines regulators.

EudraGMDP is a database operated by the EMA that supports the exchange of information on GMP compliance and non-compliance, as well as on manufacturing and importation authorizations, among European regulatory authorities and regulators outside the EU. 

As of April 2013 the database also includes information on good distribution practice (GDP) compliance; registrations of active substance manufacturers, importers and distributors; and wholesale distribution authorizations. 

Most information contained in EudraGMDP is publicly available. Confidential information is not made public. The decision on which information to make public is taken by the medicines regulatory authority in the EU Member State that adds the information to the database.

Source: European Medicines Agency