Joint Scientific Consultations (JSC)
Parallel EMA/HTA body (HTAb) Scientific Advice during Interim Period post EUnetHTA 21
[UPDATE]The Parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) under the EUnetHTA 21 service contract will have to be completed by September 2023 and all available slots have already been allocated. To bridge the interim period between the closure of EUnetHTA 21 and the full application of the HTA Regulation in January 2025, EMA and national HTAb will offer Health technology developers (HTDs) the opportunity for parallel scientific advice: HTDs will be able to apply for Parallel EMA/HTA body (HTAb) Scientific Advice from September 2023, when EUnetHTA 21 ceases to operate, until January 2025 when Regulation (EU) 2021/2282 on health technology assessment will become fully applicable.The G-BA (Gemeinsamer Bundesausschuss/Federal Joint Committee, Germany) will function as the HTA Coordination Contact and facilitates a centralised HTAb recruitment. In order to apply for a Parallel EMA/HTAb Scientific Advice, HTDs should complete the application form and submit the form and its annexes via Eudralink to the HTA Coordination Contact (interimadvice.hta@g-ba.de) copying EMA. Applicants should request such parallel scientific advice three months before the standard submission deadline. For more information, see Scientific Advice Working Party. The selection criteria, identical to the ones of the HTA Regulation, can be found again in the Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice. The result of the selection will also depend on the resources available to each HTA body. A minimum of two HTA bodies may actively participate on a voluntary basis. If the minimum number of active HTA bodies is not reached, the request will continue as EMA-only scientific advice. As an outcome of the procedure, developers will receive a scientific advice letter from EMA and individual written recommendations from participating HTA bodies. Details, also in terms of HTA bodies requesting fees for their involvement, and further instructions can be found in the Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice or will be shared upon request. HTA Coordination Contact: interimadvice.hta@g-ba.de The following documents are available for the advice procedure: · Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period · Application Form Template · Briefing Document Template · Short Study Information Template Information on the parallel scientific advice can also be found on the EMA website and the G-BA website. |
______________________________________________________________________________________________
EUnetHTA 21 Procedure (March 2021-September 2023)
The 2nd Open Call for Joint Scientific Consultations (JSCs) closed and new products for the 2nd batch of parallel EMA/EUnetHTA 21 JSC have been selected
The EUnetHTA 21 2nd Open Call for applications from the pharmaceutical industry for Joint Scientific Consultations (JSCs) closed on 31 August, 2022.
The EUnetHTA 21 Committee for Scientific Consistency and Quality (CSCQ) JSC reviewed the applications received and selected five additional JSCs to be conducted within the framework of EUnetHTA 21.
These five JSCs will be consultations on medicinal products in parallel to EMA scientific advice, starting end of October 2022. Amongst the selected JSCs there are three oncological and two non-oncological products: 5x First in class (FC), 2x Orphan designation (OD), 2x ATMP, 1x PRIME and 1x SME.
Parallel EMA/EUnetHTA 21 Joint Scientific Consultation (JSC)
Parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) provide a non-binding scientific advice, before the start of pivotal clinical trials (after feasibility / proof of concept study), in order to improve the quality and appropriateness of the data produced by the HTD in view of future HTA assessment / re-assessment.
Parallel EMA/EUnetHTA 21 JSCs should enable an exchange between the applicant and HTA agencies and regulators (EMA) at an early stage in the development process in order to allow the integration of the different requirements across multiple European Member States (e.g. choice of comparators, relevant outcomes, quality of life, patient groups) in the study design (pivotal trials & post-launch evidence generation (PLEG)) and the economic evidence generation plan. However, when consensus is not possible, the views of participating HTA bodies will be made known to the applicant.
EUnetHTA 21 (2021 – 2023) offers at least 6, up to a maximum of 8 JSCs (formerly referred to as Early Dialogues) for medicinal products. Prospective and timely advice may allow the applicant to integrate specific HTA and regulatory needs into the development plan and, therefore, fulfil the evidence requirements of both regulators and HTA bodies at the same time.
The EUnetHTA 21 partners will continue to work with the EMA to improve the consultation processes and their coordination in order to meet the demand for consultations while ensuring the best scientific quality. Detailed information regarding parallel EMA/EUnetTHA 21 JSC is available on the Parallel EMA/EUnetHTA 21 JSC page of this website.
All EMA/EUnetHTA 21 JSCs are supported by the EUnetHTA 21 JSC Secretariat (EUnetHTA21-JSC@g-ba.de), thereby benefiting from HTA scientific and administrative coordination, consolidated HTA comments, a concerted effort to find agreement among the CSCQ JSC regarding specific issues as well as a consolidated document containing EUnetHTA 21’s Final Written Recommendations. Opportunities for closed discussion amongst HTA bodies, and with regulators with mutual understanding, are maximised
Due to the tender specifications, the number of products to be selected for JSCs in EUnetHTA 21 is limited. As the number of applicants is expected to exceed the number of slots, a selection of products will be necessary. A prerequisite for a JSC is that the clinical studies (phase II/ III) and clinical investigations are still in the planning stage. Furthermore, EUnetHTA 21 will apply the same selection criteria as defined in the EU HTA regulation. The criteria for selecting from eligible JSC requests for medicinal products are:
- Unmet medical needs (no treatment or only unsatisfactory treatment available);
- First in class;
- Potential impact on patients, public health, or healthcare systems;
- Significant cross-border dimension;
- Major Union-wide added value; or
- Union clinical research priorities
Oncology products and/or ATMPs and indications for which there is no established guidance for clinical development (i.e. in absence of recent HTA evaluation in similar indication) are also given preferred consideration.
The specification of the selection criteria, their operationalisation and applicability will be further developed in the course of EUnetHTA 21.
More information can also be found in the Frequently Asked Questions (FAQ) section of the EUnetHTA 21 JSC website.
In all cases, the submitted applications must comply with the selection criteria listed above. The members of the Committee for Scientific Consistency and Quality (CSCQ) JSC will review the applications.
The Committee for Scientific Consistency and Quality (CSCQ) JSC
Within the framework of EUnetHTA 21, the JSC are carried out by the members of the CSCQ JSC, which are: AEMPS (Spain), AIFA (Italy), G-BA (Germany), HAS (France), INFARMED (Portugal), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway), TLV (Sweden) and ZIN (The Netherlands). EUnetHTA 21 offers JSCs on clinical and economic evidence generation for pharmaceutical products. EUnetHTA 21 is a one-stop-shop for the involvement of HTA bodies in JSCs with the primary contact point being the EUnetHTA 21 JSC Secretariat (EUnetHTA21-JSC@g-ba.de).
General Objectives of parallel EMA/EUnetHTA 21 JSCs
EUnetHTA 21 strives to support generation of good quality evidence for proper HTA. To this end, our objectives include:
- Support developers of medical technologies by providing a collaborative approach among a wide-range of European HTA bodies to provide consolidated advice on their product evidence generation plans while also maintaining individual HTA bodies positions where needed.
- Supply and incorporate patient and clinical expert contributions in the final recommendations provided by HTA bodies.
- Optimize the interaction with regulators for medicinal products, through parallel EMA/EUnetHTA 21 JSCs.
General Aspects and Practical Considerations
Parallel EMA/EUnetHTA 21 JSCs remain confidential and are non-binding for either of the parties involved. Secure systems are used for exchange of documents between the applicant and the EUnetHTA 21 JSC Secretariat, as well as between the EUnetHTA 21 JSC Secretariat and the participating HTA bodies.
All participants in a JSCs (including patients/patient representatives and healthcare professionals) are required to complete a Declaration of Interest (DOI) and Confidentiality Agreements form. These documents together with the DOI handling procedures are available here.
Applicants are advised to review all information available on this website prior to submitting a request. All requests must be made during EUnetHTA 21’s Open Call periods for JSC.
Further information regarding parallel EMA/EUnetHTA 21 JSC, including guidance documents and templates, can be found in the corresponding sections of the EUnetHTA 21 JSC website. Any inquiries regarding the JSCs should be directed to the EUnetHTA 21 JSC Secretariat (EUnetHTA21-JSC@g-ba.de).
Note: For JA3 Early Dialogues, please go to this link
