The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it. The European Medicines Agency (EMA) published a draft reflecting paper ...

On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development. The reflection paper considers ...

EMA's draft reflection paper promotes using patient experience data in drug regulation to enhance decision-making processes. Patient perspectives, such as quality of life, complement scientific data ...