The EU’s Member State Coordination Group on Health Technology Assessment (HTACG) has added practical detail to the joint clinical assessment (JCA) process, with a set of new documents published on 18 May covering data transparency, report publication and methodological procedure.
The transparency principles confirm that the public record from JCA will be broad. JCA reports, summary reports, company dossiers and comments received during preparation are expected to be published on the European Commission’s public webpage after the JCA report is endorsed and the Commission has completed its procedural review.
The same documents set boundaries around commercially sensitive material. Developers may identify commercially confidential information and must justify why disclosure would harm their legitimate economic interests. HTACG says trade secrets, chemical analytics and company development plans may in principle qualify. It also says information already in the public domain, clinical trial methods, clinical trial results, other clinical data and evidence-synthesis approaches are generally non-confidential. The practical issue for developers will be how far pricing-sensitive or commercially strategic material can be protected when it sits within a clinical dossier.
The publication FAQ adds further detail on the dossier record. The Commission will publish the latest dossier version, normally including appendices, but joint scientific consultation outcome documents included in a JCA dossier will not be published. Individual patient and investigator listings or narratives must not be included in the published dossier and, where requested for assessment, must be submitted separately through the HTA IT platform.
The methodological Q&A also tightens the evidence standard for the first dossier. The therapeutic indication for JCA must follow the indication submitted to the European Medicines Agency. Developers must address the assessment scope defined by PICO – the population, intervention, comparator and outcomes requested by Member States – and justify any missing analyses. Where no direct randomised comparative evidence is available, indirect comparisons should be used where possible.
The documents also clarify how JCA outputs will feed into national processes. Member States must give due consideration to published JCA reports and annex them to national HTA reports, although the reports are scientific documents and are not binding on national authorities. That makes the first EU dossier more consequential than a central clinical submission alone. It will help define the public evidence record, shape later national HTA files and require earlier decisions on confidentiality strategy, comparator selection, subgroup analyses and indirect-treatment-comparison methods.
Source: European Commission
Link: Health Technology Assessment – Member State Coordination Group adopts guiding principles on data transparency
Link: Updated – Questions and Answers on general methodological and procedural issues for joint clinical assessments
Link: New – Frequently asked questions about the publication of the Joint Clinical Assessment report
Date: 18 May 2026
