The regulation on health technology assessment (Regulation (EU) 2021/2282) established a framework for joint scientific consultations (JSC) at EU level.
JSCs enable health technology developers (HTDs) to obtain scientific consultation during the planning of the clinical studies and clinical investigations of a health technology on the information and evidence needs for a subsequent Joint Clinical Assessment (JCA).
This consultation can streamline evidence preparation for JCA and enhance the quality of evidence generation.
The HTA regulation, Commission implementing regulations, and guidance issued by the Member State Coordination Group on Health Technology Assessment (HTACG) lay out the rules and procedures for JSCs for medicinal products and for medical devices and in-vitro diagnostic medical devices.
The 2025 Work Programme of the HTACG will contain information about the number and length of request periods when health technology developers can submit requests for joint scientific consultations.
Submitting requests for JSCs
The submission of requests for JSCs will happen through the secure HTA IT platform, using the dedicated template for JSC requests.
Please note that requests for JSCs should only be submitted during the request periods published in the Annual Work Programme of the HTACG. In 2025, these periods are:
- 3 February to 3 March 2025 for medicinal products only;
- 2 to 30 June 2025 for medicinal products and medical devices.
What must health technology developers do to submit a request for JSC?
Health technology developers should contact the HTA secretariat by sending an e-mail to SANTE-HTA-JSC
ec [dot] europa [dot] eu (SANTE-HTA-JSC[at]ec[dot]europa[dot]eu).
The e-mail shall contain:
- A request by the applicant/health technology developer to access the HTA IT Platform to upload a request for JSC.
- The name, EU Login account username and e-mail address (linked to the EU Login) of a contact person from the health technology developer for the purposes of the JSC.
To create an EU Login account, please refer to this page: Help for external users (europa.eu)
NB! No commercially sensitive information shall be included in this e-mail about the product or applicant. Any commercially sensitive information shall only be uploaded in the HTA IT Platform.
Following the receipt of the e-mail, the secretariat of the HTACG will send an access link and instruct the health technology developer on how to upload the request for JSC on the HTA IT Platform.
All further product-specific information exchange with the health technology developers in a JSC will take place on the HTA IT platform which provides a secure environment for exchange of commercially sensitive information.
More information
If you have questions about joint scientific consultations, you can consult the relevant sections of the HTA regulation, Commission implementing regulations, and guidance.
