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EMA Launches Pilot Project on Analysis of Raw Data from Clinical Trials

Raw data in electronic structured format is currently not systematically included as part of marketing authorisation and variation applications submitted to EMA. However, the Regulations which govern the work carried out by EMA allow for request of raw data during the assessment process.

EMA has launched a pilot project to assess whether the analysis of ‚Äėraw data‚Äô from¬†clinical trials¬†by regulatory authorities improves the evaluation of¬†marketing authorisation applications¬†(MAAs) for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data.¬†

More information on the pilot’s objectives and on the terms of participation is available in the description of the pilot to industry.