EMA To See If Reviewing Patient-Level Data Can Speed Up Drug Evaluations

A two-year pilot will explore the many potential benefits that the analysis of raw data can bring to the EU drug evaluation process. These range from faster patient access to medicines, companies facing fewer questions, and better definition of the target treatment population.

Doctor using laptop and electronic medical record (EMR) system. Digital database of patient's health care and personal information on computer screen.
EMA is legally allowed to ask for raw data from companies at any time to support drug assessments • Source: Shutterstock

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