The pilot, which will include ten regulatory procedures in total, recently selected its sixth and seventh procedures: two initial marketing authorisation applications in oncology and gastroenterology.

Applicants or marketing authorisation holders who are planning to submit an initial or post-authorisation marketing authorisation application to EMA by the second quarter of 2024 can still express their interest to participate in the proof-of-concept pilot by writing to rawdatapilot@ema.europa.eu before recruitment concludes.

Participation in the pilot offers a unique opportunity to contribute to the pilot’s learnings which will, in turn, help the EMRN make an informed decision on the role of clinical trials raw data in the EU regulatory decision-making process. The interim pilot report, a summary of which is expected to be published in Q2 2024, will include initial insights on the role of analysis of clinical trial ‘raw data’ submitted to EMA in electronic structured format.

Further information is available on EMA’s Big Data webpage.