EMA publishes noncompliance letters

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EMA warning letters now have a publisher. Pharmafile reports that the European Medicines Agency (EMA) is now publishing the names of companies which fail to meet Good Manufacturing Practice Standards. Pharmafile says the EudraGMDP database, which includes all non-compliance report entries going back to 2007, lists 83 non-compliance reports.

Four US manufacturing sites are among the violators, preceded by China, which has 22 non-compliance notices, and India, which has 35.

The database was initially set up to make manufacturing and import approvals public and was first known as the EudraGMP.

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