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Health technology assessment - Key documents (22)
RSSPICO exercises
Implementing act on joint scientific consultations on medical devices and in vitro diagnostic medical devices
Guidance on the appointment of assessors and co-assessors for Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC)
Guidance on filling in the joint clinical assessment (JCA) dossier template – Medicinal products
Procedural guidance for JCA medicinal products
Guidance on the scoping process
Implementing Regulation (EU) 2024/2745 on conflict-of-interest rules under the EU Health Technology Assessment Regulation
Implementing Regulation (EU) 2024/2699 on exchange of information with the European Medicines Agency
Guidance on the validity of clinical studies for joint clinical assessments
Guidance on outcomes for joint clinical assessments
Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments
Scientific specifications of medicinal products subject to joint clinical assessments
Implementing Regulation (EU) 2024/1381 on joint clinical assessment of medicinal products for human use
Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons
Practical Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons
Rolling plan - Implementation of the Regulation on health technology assessment
Regulation (EU) 2021/2282 on health technology assessment
Impact Assessment - Strengthening of the EU Cooperation on Health Technology Assessment (HTA)
Proposal for a Regulation on health technology assessment
Inception Impact Assessment on Strengthening of the EU cooperation on Health Technology Assessment (HTA)