However, the imminent implementation of the HTA Regulation and introduction of Joint Clinical Assessments (JCA) in 2025 create uncertainty about the speed at which breakthrough cancer treatments will ...

Orphan drug developers face significant difficulties when navigating market access frameworks in Europe. Could greater use of ...

Ambitions for European HTA The EC has set out a number of ambitions ... time of writing – available in English. Progress of the Regulation The draft Regulation set out by the Commission is ...

In April 2025, the EU announced details about the first two medicinal products to undergo joint clinical assessments (JCAs).

EU HTA harmonisation and the EU Critical Medicines Act. These regulations are part of a larger plan to “harmonise” healthcare regulations amongst EU member states to improve outcomes for ...

At the beginning of the year, the European Commission proposed a binding regulation on health technology assessment (HTA). While pricing is a matter decided by individual member states ...

In January 2022, the HTA Regulation, which aims to harmonise the HTA process across the EU, was approved by the European Commission. For Martin Price, the new regulation has potential, but only if ...