OBJECTIVES: In 2025, Joint Clinical Assessment (JCA) for oncology drugs and advanced therapy medicinal products (ATMPs), including gene therapies, will start in the European Union (EU). The JCA's goal is to standardize the evaluation of new therapies across EU member states, reducing multiple clinical submissions within member states (MS). While the implementation is ongoing, concerns remain regarding potential hurdles and evidence requirements.

METHODS: To explore potential hurdles, uncertainties and benefits associated with JCA, publicly available statements and viewpoints from diverse stakeholders, (e.g., health authorities, industry, and patients) were reviewed. The focus was on identifying both the challenges and potential solutions for integrating JCA into existing national frameworks.

RESULTS: The search revealed three main categories of potential obstacles with the JCA. Firstly, methodological challenges such as meeting stringent evidence requirements across varied EU practices, managing complex PICOs, and potential amendments for national HTA submissions. Secondly, operational, and logistical issues like increased administrative burden and potential delays. Thirdly, Overcoming these obstacles includes engaging stakeholders at an early stage, providing resources and training to smaller MS. Key challenges involve designing clinical trials to meet diverse PICO requirements across the EU, timing, and coordination of JCA submissions with the EU market authorization process. Reducing uncertainties requires incorporating JCA needs early in development, continuous multi-stakeholder dialogue, and transparent communication.

CONCLUSIONS: JCA offers prospects for more streamlined and unified clinical evaluations of new therapies but may impose new obstacles for market entry and reimbursement of novel drugs. Overcoming these hurdles with potential future adaptations of requirements, inventive trial designs, and active stakeholder involvement could be essential to fully leverage JCA's potential and lead to prompt access to critical treatments for patients.