HORIZON-HLTH-2023-TOOL-05-01
Clinical trials of combined Advanced Therapy Medicinal Products (ATMPs) -
Call text (as on F&T portal)
View on F&T portalExpected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following Expected Outcomes:
- Healthcare providers increase their knowledge on the potential of combined ATMPs and get access to innovative treatment options with demonstrated health benefits for unmet medical needs;
- Developers and manufacturers of combined ATMPs obtain scientific evidence on the proposed therapeutic approach;
- Patients benefit from new advanced therapies delivered through the combined ATMPs;
- EU companies get a better market position in the field of combined ATMPs.
Scope:
The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal Products) according to the definition of the ATMP-regulation (EU 1394/2007, Article 2d). Such combined ATMPs are composed of an ATMP and one or more medical devices or one or more active implantable medical devices, and their cellular or tissue part must either contain viable cells or tissues, or non-viable cells or tissues liable for exerting the primary action on the human body.
The combined ATMPs should be more effective than current state-of-the-art solutions on the European market owing to improved features like personalisation, accuracy, reliability and usability and contribute to long-term sustainability (faster and affordable) of European health systems.
Research should focus on advanced stages of clinical development with regulatory work on the Medical Device part completed and safety studies of the combination product in an advanced stage.
Proposals should address all of the following activities:
- Phase 2 clinical trials and above of combined ATMPs focussing on:
- technologies ready to undergo interventional clinical trials in patients/end users assessing the usability and clinical performance, and/or
- technologies that have demonstrable safety/performance profiles and should undergo clinical validation in view of their inclusion into guidelines for specific clinical pathways.
- Delivery of safe and clinically validated combined ATMPs that are compliant with current European regulatory requirements. The related regulatory work should be considered as an essential component and the proposed work should involve consultation/interaction with competent regulatory agencies such as the European Medicines Agency (EMA) or national regulatory agency. Applicants are encouraged to seek regulatory and/or Health Technology Assessment (HTA) advice as appropriate.
The topic invites proposals that include innovative treatments for any medical condition excluding rare diseases that are ready to be assessed for clinical efficacy (performance and clinical benefit) in a specific indication on a big number of patient cohorts; already existing market solutions are not in the scope of this topic.
Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors and any other non-health related individual attributes should be taken into consideration. SME participation is strongly encouraged.
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
News flashes
Call HORIZON-HLTH-2023-TOOL-05
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 170
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 71
Total budget requested for above-threshold proposals: EUR 634,646,986.
Call HORIZON-HLTH-2023-TOOL-05
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 170
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 71
Total budget requested for above-threshold proposals: EUR 634,646,986.
Call HORIZON-HLTH-2023-TOOL-05
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 170
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 71
Total budget requested for above-threshold proposals: EUR 634,646,986.
Call HORIZON-HLTH-2023-TOOL-05
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 170
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 71
Total budget requested for above-threshold proposals: EUR 634,646,986.
Call HORIZON-HLTH-2023-TOOL-05 closed on 13 April 2023. 170 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2023-TOOL-05-01: 8 proposals
- HORIZON-HLTH-2023-TOOL-05-03: 65 proposals
- HORIZON-HLTH-2023-TOOL-05-04: 49 proposals
- HORIZON-HLTH-2023-TOOL-05-05: 23 proposals
- HORIZON-HLTH-2023-TOOL-05-08: 24 proposals
- HORIZON-HLTH-2023-TOOL-05-09: 1 proposals
Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.
Call HORIZON-HLTH-2023-TOOL-05 closed on 13 April 2023. 170 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2023-TOOL-05-01: 8 proposals
- HORIZON-HLTH-2023-TOOL-05-03: 65 proposals
- HORIZON-HLTH-2023-TOOL-05-04: 49 proposals
- HORIZON-HLTH-2023-TOOL-05-05: 23 proposals
- HORIZON-HLTH-2023-TOOL-05-08: 24 proposals
- HORIZON-HLTH-2023-TOOL-05-09: 1 proposals
Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.
Opening date: 2023-01-12 (3 years ago)
Closing date: 2023-04-13 (3 years ago)
Procedure: single-stage
Budget: 50,000,000
Expected grants: 5
Contribution: 8,000,000 - 10,000,000
This call topic has been appended 8 times by the EC with news.
-
2023-08-09
call horizon-hlth-2023-tool-05we recentl... -
2023-08-09
call horizon-hlth-2023-tool-05we recentl... -
2023-08-09
call horizon-hlth-2023-tool-05we recentl... -
2023-08-09
call horizon-hlth-2023-tool-05we recentl... -
2023-04-13
call horizon-hlth-2023-tool-05 closed on... -
2023-04-13
call horizon-hlth-2023-tool-05 closed on... -
2023-01-12
the submission session is now available... -
2023-01-12
the submission session is now available...
HORIZON-HLTH-2023-TOOL-05
Call topics are often grouped together in a call. Sometimes this is for a thematic reason, but often it is also for practical reasons.
There are 5 other topics in this call:
Showing the latest information. Found 202 versions of this call topic in the F&T portal.
Information from
- 2026-10-08_08-24-48
- 2026-10-08_08-23-49
- 2026-10-07_08-20-29
- 2026-10-07_08-19-20
- 2026-10-06_08-22-21
- 2026-10-06_08-21-46
- 2026-10-05_08-18-18
- 2026-10-05_08-17-43
- 2026-10-04_08-20-01
- 2026-10-04_08-19-05
- 2026-10-03_08-18-27
- 2026-10-03_08-17-29
- 2026-10-02_08-20-21
- 2026-10-02_08-18-38
- 2026-10-01_08-22-48
- 2026-10-01_08-21-03
- 2026-09-29_08-54-47
- 2026-09-29_08-52-34
- 2026-09-28_08-54-21
- 2026-09-28_08-52-20
- 2026-09-27_08-53-11
- 2026-09-27_08-50-56
- 2026-09-26_08-49-56
- 2026-09-26_08-47-42
- 2026-09-25_08-51-28
- 2026-09-25_08-49-14
- 2026-09-24_08-53-57
- 2026-09-24_08-51-39
- 2026-09-23_08-48-40
- 2026-09-23_08-46-30
- 2026-09-22_08-48-49
- 2026-09-22_08-46-48
- 2026-09-21_08-44-35
- 2026-09-21_08-42-19
- 2026-09-20_08-46-08
- 2026-09-20_08-43-57
- 2026-09-19_08-43-15
- 2026-09-19_08-41-07
- 2026-09-18_08-48-51
- 2026-09-18_08-46-42
- 2026-09-17_08-43-55
- 2026-09-17_08-41-48
- 2026-09-16_08-41-02
- 2026-09-16_08-38-57
- 2026-09-15_08-42-51
- 2026-09-15_08-40-40
- 2026-09-14_08-42-33
- 2026-09-14_08-40-24
- 2026-09-13_08-41-07
- 2026-09-13_08-39-07
- 2026-09-12_08-44-30
- 2026-09-12_08-42-26
- 2026-09-11_08-43-37
- 2026-09-11_08-41-23
- 2026-09-10_08-42-11
- 2026-09-10_08-40-07
- 2026-09-09_08-43-09
- 2026-09-09_08-41-04
- 2026-09-08_08-41-01
- 2026-09-08_08-38-59
- 2026-09-07_08-40-43
- 2026-09-07_08-38-51
- 2026-09-06_08-39-20
- 2026-09-06_08-37-07
- 2026-09-05_08-37-48
- 2026-09-05_08-35-51
- 2026-09-04_08-36-03
- 2026-09-04_08-33-56
- 2026-09-03_08-36-28
- 2026-09-03_08-34-26
- 2026-09-02_08-37-48
- 2026-09-02_08-35-58
- 2026-09-01_08-37-22
- 2026-09-01_08-35-15
- 2026-08-31_08-40-56
- 2026-08-31_08-38-35
- 2026-08-30_08-30-36
- 2026-08-30_08-28-43
- 2026-08-29_08-33-25
- 2026-08-29_08-31-22
- 2026-08-28_08-37-10
- 2026-08-28_08-35-12
- 2026-08-27_08-25-47
- 2026-08-27_08-23-56
- 2026-08-25_08-32-32
- 2026-08-25_08-30-43
- 2026-08-24_08-27-46
- 2026-08-24_08-26-01
- 2026-08-23_08-25-36
- 2026-08-23_08-23-47
- 2026-08-22_08-26-34
- 2026-08-22_08-24-45
- 2026-08-21_08-20-43
- 2026-08-21_08-18-49
- 2026-08-20_08-25-32
- 2026-08-20_08-23-46
- 2026-08-19_08-24-20
- 2026-08-19_08-22-37
- 2026-08-18_08-19-27
- 2026-08-18_08-17-37
- 2026-08-17_08-20-38
- 2026-08-17_08-18-51
- 2026-08-16_08-15-36
- 2026-08-16_08-13-47
- 2026-08-14_08-18-43
- 2026-08-14_08-16-53
- 2026-08-13_08-16-05
- 2026-08-13_08-14-23
- 2026-08-12_08-14-56
- 2026-08-12_08-13-08
- 2026-08-11_08-16-57
- 2026-08-11_08-15-05
- 2026-08-10_08-12-32
- 2026-08-10_08-11-01
- 2026-08-09_08-12-43
- 2026-08-09_08-10-59
- 2026-08-08_08-11-26
- 2026-08-08_08-09-45
- 2026-08-07_08-10-02
- 2026-08-07_08-08-17
- 2026-08-06_08-10-59
- 2026-08-06_08-09-02
- 2026-08-05_08-12-21
- 2026-08-05_08-10-34
- 2026-08-04_08-12-50
- 2026-08-04_08-11-02
- 2026-08-03_08-10-37
- 2026-08-03_08-08-52
- 2026-08-02_08-09-17
- 2026-08-02_08-07-35
- 2026-08-01_08-10-52
- 2026-08-01_08-09-12
- 2026-07-31_08-09-11
- 2026-07-31_08-07-25
- 2026-07-30_08-07-32
- 2026-07-30_08-05-53
- 2026-07-29_08-09-42
- 2026-07-29_08-07-56
- 2026-07-28_08-08-22
- 2026-07-28_08-06-47
- 2026-07-27_08-03-49
- 2026-07-27_08-02-08
- 2026-07-26_08-01-14
- 2026-07-26_07-59-42
- 2026-07-25_08-01-51
- 2026-07-25_08-00-20
- 2026-07-24_08-02-30
- 2026-07-24_08-00-48
- 2026-07-23_08-02-31
- 2026-07-23_08-00-41
- 2026-07-22_08-03-51
- 2026-07-22_08-02-14
- 2026-07-20_08-00-54
- 2026-07-20_07-59-16
- 2026-07-19_08-01-42
- 2026-07-19_07-59-49
- 2026-07-18_08-00-52
- 2026-07-18_07-59-18
- 2026-07-17_08-00-18
- 2026-07-17_07-58-37
- 2026-07-16_07-42-20
- 2026-07-16_07-41-08
- 2026-07-14_07-40-50
- 2026-07-14_07-39-32
- 2026-07-12_07-41-39
- 2026-07-12_07-40-18
- 2026-07-10_07-40-12
- 2026-07-10_07-39-03
- 2026-07-09_07-40-16
- 2026-07-09_07-39-06
- 2026-07-08_07-40-09
- 2026-07-08_07-38-55
- 2026-07-07_07-39-38
- 2026-07-07_07-38-31
- 2026-07-06_07-40-20
- 2026-07-06_07-39-04
- 2026-07-05_07-36-53
- 2026-07-05_07-35-44
- 2026-07-04_07-38-25
- 2026-07-04_07-37-21
- 2026-07-03_07-38-10
- 2026-07-03_07-36-57
- 2026-07-02_07-37-20
- 2026-07-02_07-36-04
- 2026-07-01_07-57-56
- 2026-07-01_07-57-29
- 2026-06-30_09-49-13
- 2026-06-30_07-54-30
- 2026-06-29_11-35-04
- 2026-06-29_07-57-41
- 2026-06-28_09-32-08
- 2026-06-28_07-52-51
- 2026-06-27_09-32-41
- 2026-06-27_07-53-09
- 2026-06-27_07-52-44
- 2026-06-26_07-23-20
- 2026-06-25_07-46-13
- 2026-04-14_07-04-15
- 2025-07-06_03-35-11
- 2024-11-04_17-25-39
- 2024-09-30_21-22-22
- 2024-03-30_14-17-32
Check the differences between the versions.
Annotations
Events
Hand-picked events relevant to this call topic.
No events yet
There are currently no events linked to this call topic.
Timeline
Call published · 30 Sep 2024 (2 years ago)
All expected milestones for this call have passed.
Work programme published
07 Oct 2022 · est.
Call opens
12 Jan 2023
Call closes
13 Apr 2023
Outcome expected
13 Sep 2023 · est.
Grant agreement signed
13 Dec 2023 · est.
Call published
30 Sep 2024
-
Work programme published Estimated
07 Oct 2022 · 4 years ago
Topics are listed in the Work Programme before the call opens. Spotting this early gives you a head start on partner search and proposal planning.
-
Call opens
12 Jan 2023 · 3 years ago
Submissions can be made from this date.
-
Call closes
13 Apr 2023 · 3 years ago
Deadline to submit a proposal.
-
Outcome expected Estimated
13 Sep 2023 · 3 years ago
The maximum time to inform applicants of the evaluation outcome is five months after the call closes.
-
Grant agreement signed Estimated
13 Dec 2023 · 2 years ago
The maximum time to sign the grant agreement is three months after applicants are informed of the outcome.
-
Call published
30 Sep 2024 · 2 years ago
This topic was first published in TopicTree.
Funded Projects
Loading...
Project information comes from CORDIS (for Horizon 2020 and Horizon Europe) and will be sourced from F&T Portal (for Digital Europe projects)
Ecosystem bubbles
This call topic is part of the following thematic bubbles.
Not part of a bubble yet
This call topic has not been grouped into an ecosystem bubble.