The regulation on health technology assessment (Regulation (EU) 2021/2282) established a framework for joint clinical assessments (JCA) at EU level. These assessments support member states’ national HTA processes, providing a scientific analysis of clinical evidence on the relative effects of a health technology (a medicinal product or a medical device) on health outcomes.
The HTA regulation, Commission implementing regulations, and guidance issued by the Member State Coordination Group on Health Technology Assessment (HTACG) lay out the rules, procedures and methodologies for joint clinical assessments for medicinal products.
What is in scope?
From 12 January 2025, new medicines for the treatment of cancer, as well as advanced therapy medicinal products will be subject to joint clinical assessments. See the information document issued by the HTACG on the scientific specifications of the products in scope.
How does the process start?
- When submitting a marketing authorisation application for a relevant medicinal product to the European Medicines Agency (EMA) after 12 January 2025, health technology developers must submit simultaneously the summary of product characteristics and the clinical overview of the marketing authorisation application to the HTA secretariat. This information will be used to establish the scope of the joint clinical assessment.
- The EMA will also inform the HTA secretariat of the submission of a marketing authorisation application.
- The JCA process formally begins upon appointing an assessor and a co-assessor for joint clinical assessment. The HTA secretariat will inform the health technology developer about the start of the process.
How will health technology developers communicate with the HTA secretariat during the JCA?
All product-specific communication in the context of a joint clinical assessment will take place on the secure HTA IT platform. However, the HTA IT platform is not a messaging platform and it is also not accessible without prior notification sent to the HTA secretariat, which will grant access to use the platform.
Therefore, the health technology developers should notify the HTA secretariat by e-mail about their intention to upload documents on the HTA IT platform related to any new product subject to joint clinical assessment.
- For general enquiries: SANTE-HTA
ec [dot] europa [dot] eu (SANTE-HTA[at]ec[dot]europa[dot]eu) - For product-specific JCA: SANTE-HTA-JCAec [dot] europa [dot] eu (SANTE-HTA-JCA[at]ec[dot]europa[dot]eu)
What should health technology developers do at the start of the JCA process?
Health technology developers should contact the HTA secretariat by sending an e-mail to SANTE-HTA-JCAec [dot] europa [dot] eu (SANTE-HTA-JCA[at]ec[dot]europa[dot]eu). They should notify the HTA secretariat that they will submit a marketing authorisation application to the EMA for a product in scope for JCA and request an access link to the HTA IT platform.
However, if a health technology developer has already submitted early information (for example, a letter of intent) on the HTA IT platform for a product, they should skip this step and go to the section below on “If the health technology developer has already submitted early information”.
Please note that the HTA secretariat grants each access link to the health technology developer.
- the access link is personalised and product-specific.
- only the person who requested access can use it
- a specific link should be requested separately for each product subject to JCA.
The e-mail sent to the HTA Secretariat shall contain:
- A request by the applicant/health technology developer to access the HTA IT Platform to upload information concerning a product subject to JCA.
- 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 JCA.
To create an EU Login account, please refer to this page: Help for external users
NB! No commercially sensitive information about the product or applicant shall be included in this e-mail. Any commercially sensitive information shall only be uploaded to the HTA IT Platform.
Following the receipt of the e-mail, the HTA secretariat will send an access link and instruct the health technology developer on how to upload information on the HTA IT Platform.
If the health technology developer has already submitted early information (for example, a letter of intent) to the HTA secretariat about a product, the health technology developer can use the same access or upload link that was used for the initial submission.
There is no need to contact the HTA secretariat by e-mail before uploading this further information.
More information
For questions or information about joint clinical assessments:
