EMA publishes Q&A on raw data in medicine evaluation pilot scheme

Article summary

The European Medicines Agency (EMA) has published a Q&A document to support its pilot on using raw data in medical evaluation. Raw data includes clinical laboratory results, imaging data and patient medical charts. Currently, applicants must submit data in aggregated formats, such as clinical summaries or as individual data in PDF listings. The pilot, launched in July 2022, aims to assess whether utilising raw data stored in an electronic structured format will speed up the process of medicine evaluation. The Q&A covers general questions about the pilot, terms of participation, how data packages should be submitted and technical questions on raw data submission. The pilot will run for two years and is considered a key activity under the ‘priority recommendations of the HMA/EMA Big Data Task Force’.