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Transparancy of clinical trial reports assured

Transparancy of clinical trial reports assured

Brussels - We welcome the decision of the Court of Justice of the European Union that safeguards the publicity principle and, in particular, the publication of clinical research reports.

The publication of clinical research reports of medicines by the European Medicines Agency was recently challenged by a pharmaceutical company for commercial reasons (see news of 21 January). However, the Court confirmed today that clinical trial reports do not benefit from a general presumption of confidentiality.

EMA can now continue to publish study reports on their website. An important source of information about the efficacy and safety of medicines will thus remain public. This is excellent news for patients and caregivers.