Joint HTA Work
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 ID | Sub-Deliverable | Title | Public consultation of draft deliverable * | Public consultation until | Publication of Project Plan * | Finalisation of deliverable * |
|---|---|---|---|---|---|---|
| Methodological Deliverables | ||||||
| D4.2 | Scoping process | 02-05-2022 | 31-05-2022 | 03-12-2021 | 09-09-2022 (Date of publication 12-09-2022) | |
| D4.3 | D4.3.1 | Practical Guideline Direct and Indirect Comparisons | 01-08-2022 | 30-08-2022 | 03-12-2021 | 04-11-2022 |
| D4.3.2 | Methodological Guideline on Direct and indirect comparisons | 02-05-2022 | 31-05-2022 | 29-07-2022 (Date of publication 29-07-2022) | ||
| D4.4 | Endpoints | 03-10-2022 | 01-11-2022 | 03-12-2021 | 13-01-2023 | |
| D4.5 | Applicability of evidence | 04-07-2022 | 02-08-2022 | 03-12-2021 | 04-11-2022 | |
| D4.6 | Validity of clinical studies | 04-07-2022 | 02-08-2022 | 03-12-2021 | 04-11-2022 | |
| D4.7 | D4.7.1/2 | Assessment of High-Risk Medical Devices | 02-05-2022 | 31-05-2022 | 03-12-2021 | 29-07-2022 (Date of publication 29-07-2022) |
| D4.7.3/4 | EUDAMED data reporting template / Guidance for EUDAMED-based TISP process | 06-06-2022 | 05-07-2022 | 03-12-2021 | 30-09-2022 | |
| Joint Clinical Assessment (JCA)/ Collaborative Assessments (CA) | ||||||
| D5.1 | JCA/CA Submission Dossier Template | 04-07-2022 | 02-08-2022 | 03-12-2021 | 04-11-2022 This deliverable is delayed to ensure it is fit-for-purpose with the HTA Regulation. | |
| D5.2 | JCA/CA Assessment Report Template | 01-08-2022 | 30-08-2022 | 03-12-2021 | 04-11-2022 | |
| D5.3 | D5.3.1 | Procedural guidelines for appointing assessors and co-assessors | 07-03-2022 | 05-04-2022 | 03-12-2021 | 03-06-2022* (Date of publication: 08-06-2022) |
| D5.3.2 | HTAb technical expert working groups | 20-04-2022 | 20-05-2022 | 29-07-2022 (Date of publication 29-07-2022) | ||
| D5.4 | Production of JCA/CA on medicinal products and medical devices | Not applicable | 03-12-2021 | Please 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 JSC | Not applicable | 03-12-2021 | Please note that for the actual JSC productions nothing will be made public due to confidentiality procedures. | ||
| D6.2/3 | Template Briefing Book | 01-07-2023 | 31-07-2023 | 03-12-2021 | 29-09-2023 | |
| Template JSC Report | Not applicable | 03-12-2021 | 29-09-2023 | |||
| D6.4 | Procedural Guidance JSC | 01-07-2023 | 31-07-2023 | 03-12-2021 | 29-09-2023 | |
| Transversal Activities | ||||||
| D7.1 | Guidance for the interaction between HTD and HTA (for JCA and JSC) | 20-07-2022 | 19-08-2022 | 03-12-2021 | 30-09-2022 | |
| D7.2/3 | Guidance and template for the interaction with patient representative, healthcare professional and other experts | 01-08-2022 | 30-08-2022 | 03-12-2021 | 04-11-2022 (Date of publication: 04-04-2023) | |
| D7.5 | Guidance for identifying and handling conflict of interest (COI) and declaration of interest (DOI) – and EUnetHTA confidentiality agreement (ECA) forms | Not applicable | 03-12-2021 | 16-03-2022 |
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.
