European Commission introduces new JCA eligibility tool and updates early information guidance

The European Commission has introduced a new eligibility checker and updated guidance for the submission of early information for Joint Clinical Assessments, providing product developers with clearer processes for identifying products within scope and preparing for assessment earlier in the regulatory and evidence-generation pathway.

The Baseline

• A new European Commission eligibility checker allows health technology developers to assess whether a medicinal product may fall within the scope of JCA.
• Updated European Commission and European Medicines Agency guidance clarifies how JCA eligibility should be declared and communicated during the pre-authorization process.
• Earlier identification of products subject to JCA could support earlier planning of PICO requirements, comparator strategies and evidence generation.

The European Commission has updated the early stages of the Joint Clinical Assessment (JCA) process, introducing a new eligibility checker alongside revised guidance on how medicinal product developers should provide early information for assessments.

The changes build on the implementation of the EU Health Technology Assessment Regulation (EU HTAR), which has applied since January 12, 2025. JCA provides an EU-level assessment of the relative clinical effectiveness and safety of a health technology, while decisions on economic evaluation, pricing and reimbursement remain with individual Member States.

JCA currently applies to medicinal products containing new active substances where the therapeutic indication is the treatment of cancer, as well as advanced therapy medicinal products. The requirements will extend to orphan medicinal products from January 13, 2028, and other medicinal products covered by the Regulation from January 13, 2030.

The new JCA eligibility checker, available through the Commission's HTA webpage as an EU Survey tool, is designed to help developers determine whether a medicinal product potentially falls within the scope of the Regulation.

The Commission has also updated its guidance on submitting early information for JCA following revised European Medicines Agency (EMA) pre-authorization procedural guidance published on August 19, 2026.

Under the EMA process, applicants and health technology developers indicate through Eligibility and Letter of Intent forms submitted via the EMA's IRIS portal whether a marketing authorization application falls within Article 7 of the EU HTAR and is therefore subject to JCA. Where a product is considered in scope, the developer is also required to notify the Secretariat of the Member State Coordination Group on HTA.

The corresponding Commission guidance outlines how developers should transmit this early information and obtain access to the HTA IT Platform, further connecting regulatory and HTA procedures before assessment begins.

The changes come as JCA activity increases, with 22 assessments initiated since January 2025 and three completed. Three have also been discontinued, including two where substantial evidence gaps were not addressed. This rollout is taking place against a backdrop of wider geopolitical and drug pricing pressures, including uncertainty created by US Most-Favored-Nation (MFN) pricing policy. With the HTA Coordination Group reportedly expecting 70–75 medicines to have entered the JCA process by the end of 2026, clearer guidance on eligibility and early requirements could help reduce procedural uncertainty as activity scales up.

For evidence-generation teams, earlier clarification of JCA eligibility provides more time to prepare for the assessment across clinical development, HEOR, RWE, market access and regulatory affairs. With JCAs structured around PICOs, early consideration of the relevant patient populations, interventions, comparators and outcomes can help teams assess whether planned clinical evidence will meet the anticipated requirements.

This could bring potential evidence gaps into view earlier, including where additional evidence synthesis, indirect comparisons or RWE may be needed to address comparators or populations not covered by the clinical development program. Earlier planning could also support preparation of the JCA dossier and alignment between evidence required for the EU-level assessment and subsequent national HTA processes.