英文【精鼎洞见】欧盟联合临床评估（JCA）：申办方实施指南-所有领域法规与上市咨询服务

JCA in the EU: A roadmap for sponsors ContentsIntroduction 3 Areas of challenge for sponsors 4 How sponsors can prepare for the JCA implementation 6 Case study: JCA preparation in action 10Optimize your JCA readiness 11 Authors 12 3 | INTRODUCTIONThe Joint Clinical Assessment (JCA) framework (Regulation (EU) 2021/2282) was implemented on January 12, 2025 for all new medicinal products for oncology, and advanced therapy medicinal products (ATMPs). From 2028, this process will apply to orphan medicinal products, and from 2030 onwards, for all other products not previously included. Biosimilars, generics, and all products with existing marketing authorization by European Medicines Agency (EMA) in the European Union (EU) are excluded, even if applications are submitted for new indications. The goal of the JCA framework is to improve the process for evaluating the clinical evidence of new medicines across the 27 EU member states, addressing concerns regarding equity, timeliness and access. The output of the JCA process is a report that provides a single, harmonized evaluation of the clinical evidence for new treatments for all EU countries. It is a factual description of the relative effects observed for analyzed health outcomes, including numerical results, confidence intervals, and an analysis of scientific uncertainty and evidence quality. The report is expected to deliberately avoid value judgments, rankings, conclusions on overall benefit or clinical added value, and recommendations on the medicinal product’s use or positioning within therapeutic strategies. Member states retain responsibility for determining the clinical added value of medicinal products within their specific healthcare contexts, as the relevance of analyses in the JCA report may vary by country. This approach allows for flexibility in considering local factors while utilizing the JCA report as a foundation. The JCA report is intended to lay the groundwork for pricing and reimbursement negotiations with HTA bodies at the member state level, facilitating timely decisions within each market. JCA is expected to increase collaboration and efficiency by avoiding duplication of efforts. This approach could facilitate more equitable and timely access to new, innovative treatments across member states, particularly benefiting smaller markets that historically face delays in product launches or have limited resources for conducting their own HTA evaluations. As of July 2025, the JCA process is underway for six oncology products, including ATMPs, with assessments expected to be published in 2026. For 2025, it is estimated that 17 oncology products and eight ATMPs will undergo JCA evaluation.IntroductionWho are the 27 EU member states? The countries participating in the EU JCA: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Sl