EU HTA Guides
Evergreen guides to the key requirements of Joint Clinical Assessment.
EU HTA guides to the JCA process, JCA dossier and Joint Scientific Consultation
JCA evidence assessment: Methodological requirements for RCTs, indirect comparisons and non-randomised evidence
Evidence assessment in a Joint Clinical Assessment (JCA) examines the relative clinical effectiveness and safety of a medicine against the PICO questions defined in the assessment scope. The suitability of available studies, the validity of direct and indirect comparisons, and uncertainty around the results determine how findings can be interpreted.
JCA scoping and PICO: Assessment scope, comparators and evidence planning under EU HTA
PICO scoping determines which clinical questions will be addressed in a Joint Clinical Assessment (JCA). The assessment scope is developed from the requirements of EU Member States and may cover multiple populations, comparators and outcomes. For health technology developers, it determines which clinical evidence needs to be addressed in the JCA dossier and where additional analyses may be necessary.
Joint Scientific Consultation (JSC): Process, eligibility and scientific advice under EU HTA
A Joint Scientific Consultation (JSC) enables health technology developers (HTDs) to seek scientific advice on the evidence likely to be required for a subsequent Joint Clinical Assessment (JCA) while clinical studies are still being planned. It supports early decisions on patient populations, comparators, outcomes and statistical analyses without prejudging the subsequent assessment.
Joint Clinical Assessment (JCA): Overview, process and timelines under EU HTA
Joint Clinical Assessment (JCA) is the joint European assessment of the relative clinical effectiveness and safety of certain health technologies. It addresses clinical questions submitted by EU Member States and is coordinated with the EU marketing authorisation procedure. The process comprises seven key stages, from initiation and PICO scoping to dossier submission, assessment and publication of the JCA report.
JCA dossier: Structure, evidence requirements and submission under EU HTA
The JCA dossier is the structured submission of clinical evidence by a health technology developer (HTD) for a Joint Clinical Assessment (JCA). It addresses the PICO questions in the final assessment scope and documents relevant studies, evidence searches, direct and indirect comparisons, and findings on relative clinical effectiveness and safety. The medicinal-product dossier template comprises six main sections and Appendices A to D.