In July 2022, EMA announced the submission of the first raw data to their pilot study of assessing the impact of individual patient data from a clinical study in regulatory decision-making. The pilot study has begun in July 2022 and selected applicants can submit raw data to EMA as a part of their initial or post-authorization marketing applications. Raw data refers to patients’ clinical laboratory data, imaging data, and medical charts.

Unlike the previous practice, raw data are now stored in electronic structured formats, making it more convenient for regulators to visualize and analyze them.

Danish Medicines Agency, a contracting subsidiary of EMA, is conducting the analysis and visualization of data. As of September 2022, 10 regulatory procedures are expected to be submitted as part of the pilot. Regulatory procedures should be selected early, preferably after the letter of intent is submitted as well as before the application is submitted.

Considerations and requirements for regulatory procedures selected for the PoC pilot apply to individual study’s data standards, type of analyses, and communication of results.

In December’s newsletter, EMA announced that it had received an initial marketing authorization application for the treatment of a neurological disorder, which contains raw data.

Applicants and MAHs can find information about the pilot, data protection-related documents, and guidance on EMA’s Big Data Webpage.