The European Medicines Agency (EMA) has launched a pilot project to assess the benefits of analyzing raw data from clinical trials by regulatory authorities when evaluating marketing authorization applications (MAAs) for new medicines, as well as post-authorization applications. Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualization, such as clinical laboratory results, imaging data, and patient medical charts. Currently, the European medicines regulatory system does not routinely require the submission of raw data in the context of a MAAs or post-authorization applications. The pilot project is open to applicants or Marketing Authorization Holders (MAHs) submitting MAAs or post-authorization applications and is expected to last up to two years, including approximately ten regulatory procedures submitted to EMA from September 2022. The pilot will fully comply with data protection legislation requirements. The pilot is an outcome of one of the ten priority recommendations issued by the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) in 2020 which highlighted the need to strengthen the network’s capability to analyse data collected at individual patient level to better inform regulatory decision making. The pilot is expected to bring potential benefits such as faster evaluation through fewer questions being put to applicants and a better definition of the target treatment population, thus enabling faster and better access to new medicines for patients. Upon completion of the pilot, EMA will organize a workshop with relevant stakeholders to discuss the learnings and will also publish a summary report.


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