EMA publishes first Joint Clinical Assessment under the new EU HTA regulation and updated report on the use of real-world evidence
The first Joint Clinical Assessment (JCA) for a new oncology medicine has been published under the EU HTA Regulation, marking an important step towards more coordinated assessment of innovative medicines across Europe.
The new framework is intended to support Member States by providing joint clinical evidence assessments that can inform national HTA and reimbursement processes. It currently applies to new oncology medicines and advanced therapy medicinal products, before expanding to orphan medicines in 2028 and all medicinal products from 2030.
The European Medicines Agency (EMA) has also published its fourth progress report on the use of real-world evidence (RWE) in medicines regulation, highlighting the increasing role of real-world healthcare data in supporting regulatory decision-making across Europe.
According to the report, 108 research topics were assessed and 88 studies were completed or underway during the reporting period—an increase of almost 50% compared to the previous year. Around 30% of studies directly informed active regulatory procedures, while others contributed to methodological advances, clinical understanding, public health preparedness, and medicines shortage management.
Overall, the report states that RWE is gradually moving from a complementary source of information to an increasingly important regulatory tool, suggesting opportunities for research and evidence-generation.
