Parallel EMA/HTA Joint Scientific Consultations (JSC)
Note: For JA3 Early Dialogues, please go to this link.
On 17 September 2021, HaDEA signed the Service Contract for the Provision of Joint Health Technology Assessment (HTA) Work Supporting the Continuation of EU Cooperation on HTA. The contract will run for 24 months, and until 16 September 2023.
EUnetHTA 21 work will build on the achievements and lessons learned from the EUnetHTA Joint Actions and focus on supporting a future EU HTA system under the HTA Regulation.
The EUnetHTA 21 joint consortium is led by ZIN (The Netherlands) and includes the following HTA agencies: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), IQWIG (Germany), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway) and TLV (Sweden).
More information on this service contract and on the activities that will be implemented will be available here on the EUnetHTA website.
Parallel EMA/HTA Joint Scientific Consultations (JSC) between EUnetHTA 21 and the European Medicines Agency
Since July 2017, EUnetHTA and the European Medicines Agency (EMA) have offered Parallel EMA/HTA JSC on evidence generation plans. Parallel Consultations aim to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies on their development plans to support decision-making on marketing authorisation, health technology assessment, and reimbursement of new medicines at the same time. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies.
This initiative has replaced the Parallel Scientific Advice procedure by EMA and HTA bodies which required medicine developers to contact Member States’ HTA bodies individually.
It also builds on previous initiatives and pilots on HTA-regulatory collaboration led by EMA, EUnetHTA 21 and the European Commission. These include the pilot on regulatory-HTA parallel advice, EUnetHTA 21’s early dialogue initiative, the SEED project financed by the European Commission, and joint research on levels of alignment between regulators and HTAs in parallel advice.
The procedure is a single gateway for Parallel EMA/HTA JSC with EMA and HTA bodies on their evidence-generation plans.
The main benefits of the Parallel EMA/HTA JSC procedure include:
- Streamlined procedure for applicants;
- Increased mutual understanding and problem-solving ability between EMA and HTA bodies through a more structured interaction;
- Improved coordination with, and greater participation of HTA bodies in parallel consultations through EUnetHTA 21`s Committee for Scientific Consistency and Quality (CSCQ) JSC and the EUnetHTA 21 JSC Secretariat.
The EUnetHTA 21 JSC Secretariat facilitates the centralised recruitment of HTA bodies.
Patients/Patient representatives and healthcare professionals also participate in the Parallel EMA/HTA JSC procedure on a routine basis so that their views and experiences are incorporated into discussions.
EMA’s scope and the fees charged for this procedure are the same as for standard scientific advice. For more information, see fees payable to EMA.
EMA and EUnetHTA 21 provide common templates which medicine developers should use to provide information and questions as part of the procedure. The guidance document is currently updated and will be published shortly.
All requests for EUnetHTA 21 participation in a Parallel EMA/HTA JSC must be made during a EUnetHTA 21 Open Call for JSC requests.
For information on the participation of HTA bodies, please contact the EUnetHTA 21 JSC Secretariat.
For information regarding the regulatory aspects, please contact the EMA scientific advice Secretariat.
For more information on JSC, please follow this link.