The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is ...

EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and ...

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 ...

EMA and US FDA set common principles for artificial intelligence in medicine development: Amsterdam, The Netherlands Friday, January 16, 2026, 11:00 Hrs [IST] European Medicines A ...

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 ...