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.

Participating in the pilot presents a unique opportunity to contribute to its learnings, which will help the European Medicines Regulatory Network make informed decisions regarding the role of clinical trial raw data in the scientific evaluation of medicines. The interim pilot report, of which a summary is expected to be published in Q2 2024, will include initial insights on the value of analysing clinical trial raw data that has been submitted by an applicant or marketing authorisation holder to EMA in an electronic structured format.

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