Joint HTA Work

Services

In the below table you can find all deliverables that are planned under the EUnetHTA 21, which procudes the deliverables under the Third EU Health Programme through a service contract with the European Health and Digital Executive Agency (HaDEA) acting under the mandate from the European Commission. For all EUnetHTA 21 deliverables the future EU HTA Regulation will serve as a basis and the past EUnetHTA Joint Action 3 experiences will be taken into account. With the deliverables, EUnetHTA 21 is supporting the development of guidance documents to be adopted by the Coordination Group and/or drafting of implementing legislation by the European Commission, thus facilitating the subsequent implementation of the HTA regulation. 

Deliverable IDSub-DeliverableTitlePublic consultation of draft deliverable *Public consultation untilPublication of Project Plan *Finalisation of deliverable *
Methodological Deliverables      
D4.2 Scoping process02-05-202231-05-202203-12-202129-07-2022
D4.3D4.3.1Comparators and comparisons01-08-202230-08-202203-12-202104-11-2022
 D4.3.2Methodological Guideline on Direct and indirect comparisons02-05-202231-05-2022 29-07-2022
D4.4 Endpoints03-10-202201-11-202203-12-202113-01-2023
D4.5 Applicability of evidence04-07-202202-08-202203-12-202104-11-2022
D4.6 Validity of clinical studies04-07-202202-08-202203-12-202104-11-2022
D4.7D4.7.1/2Assessment of High-Risk Medical Devices02-05-202231-05-202203-12-202129-07-2022
 D4.7.3/4EUDAMED data reporting template / Guidance for EUDAMED-based TISP process06-06-202205-07-202203-12-202130-09-2022
Joint Clinical Assessment (JCA)/ Collaborative Assessments (CA)      
D5.1 JCA/CA Submission Dossier Template02-05-202231-05-202203-12-202129-07-2022
D5.2 JCA/CA Assessment Report Template01-08-202230-08-202203-12-202104-11-2022
D5.3D5.3.1Procedural guidelines for appointing assessors and co-assessors07-03-202205-04-202203-12-202103-06-2022
 D5.3.2Technical expert networks20-04-202220-05-2022 29-07-2022
D5.4 Production of JCA/CA on medicinal products and medical devicesNot applicable  03-12-2021Please note once the compound/medical device is known for the specific JCA/CA, a specific project plan will then be published
Joint Scientific Consultations (JSC)      
D6.1 Production JSCNot applicable 03-12-2021Please note that for the actual JSC productions nothing will be made public due to confidentiality procedures.
D6.2/3 Template Briefing Book01-08-2023 31-08-202303-12-202102-10-2023
  Template JSC ReportNot applicable 03-12-202102-10-2023
D6.4 Procedural Guidance JSC01-08-202331-08-202303-12-202102-10-2023
Transversal activities      
D7.1 Guidance for the interaction between HTD and HTA (for JCA and JSC)20-07-202219-08-202203-12-202130-09-2022
D7.2/3 Guidance and template for the interaction with patient representative, healthcare professional and other experts01-08-202230-08-202203-12-202104-11-2022
D7.5 Guidance for identifying and handling conflict of interest (COI) and declaration of interest (DOI) – and EUnetHTA confidentiality agreement (ECA) formsNot applicable 03-12-202129-04-2022

Abbreviations: COI=Conflict of Interest; DOI=Declaration of Interest; ECA=EUnetHTA Confidentiality Agreement; JCA=Joint Clinical Assessment; JSC=Joint Scientific Consultation; HTA=Health Technology Assessment; HTD=Health Technology Developer.

* The timelines below are anticipated timelines and could be subject to change. Please note that it will take a few days to publish the final deliverable after it is finalised and endorsed by the Consortium Executive Board (CEB).
**Please note that SOPs are considered internal documents and therefore will not be made publicly available.