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 ...

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 is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations. On 3 May 2024, the European Medicines Agency (EMA) initiated a public ...

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 ...