EMA is ready to support the implementation of the new regulation on health technology ... to new medicines. In the European Union (EU), a centrally authorised medicine is accessible to patients when ...

High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD Developing clinical trials to provide good evidence for very rare diseases, so that ...

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms ...

A new pan-European initiative aimed at creating ... collecting insights and informing regulatory and Health Technology Assessment (HTA) policies to enhance representativeness in clinical studies.

Access to novel medicines continues to vary widely across EU member states. Though health remains mostly ... the W.A.I.T. study reveals. The European Medicines Agency has authorised 167 innovative ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...

In its first meeting of 2025, the European Medicines Agency ... EMA’s accelerated assessment program because it is considered to be of major public health interest, the agency said in a press ...

to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. If granted marketing authorization ...