European Commission Guidance: New Eligibility Tool and Early Information for joint clinical assessments

Sharan Murugan
13 hours ago
5 min read

Joint Clinical Assessments (JCA) provide a framework for assessing clinical evidence on the relative effects of health technologies on health outcomes at the EU level. For medicinal products within the scope of the Health Technology Assessment (HTA) Regulation, health technology developers need to provide information early in the process so that the JCA can be prepared and the relevant HTA procedures can begin.

The European Commission has updated its guidance on the submission of early information for JCA of medicinal products. The updated approach explains how applicants and health technology developers should identify whether a marketing authorisation application falls within the scope of the HTA Regulation and how to provide the required early information to the HTA Secretariat. A new JCA eligibility checker is also available to help developers determine whether a medicinal product is potentially within the scope of a JCA.

Why Early Information for JCA Is Important

Since 12 January 2025, medicinal products falling within the relevant scope of the HTA Regulation are subject to JCA. Initially, this includes medicinal products with new active substances for which the therapeutic indication is the treatment of cancer and advanced therapy medicinal products.

From 13 January 2028, medicinal products designated as orphan medicinal products will also be subject to JCA. From 13 January 2030, all other medicinal products falling within the scope of Article 7 of the HTA Regulation will be subject to JCA.

The early information process is intended to help health technology developers identify products that may be subject to JCA and prepare for the assessment at an early stage. The European Commission states that the JCA eligibility checker provides a simple way for developers to check whether a medicinal product is potentially within the scope of a JCA.

Identifying Whether a Product Is Subject to JCA

The updated process links the JCA eligibility assessment with information submitted to the European Medicines Agency (EMA).

Applicants and health technology developers should declare through the EMA Eligibility and Letter of Intent forms, submitted via the IRIS portal, whether their marketing authorisation application falls within the scope of the HTA Regulation and is therefore subject to JCA.

The Member State Coordination Group on Health Technology Assessment has also published scientific specifications for medicinal products subject to JCA to support identification of products within scope. Developers can use these specifications together with the JCA eligibility checker when determining whether a product may be subject to JCA.

Providing Early Information to the HTA Secretariat

When an applicant or health technology developer declares to the EMA that the application falls within the scope of the HTA Regulation, the developer is requested to notify the HTA Secretariat of the Member State Coordination Group on Health Technology Assessment.

The developer should request access to the HTA IT Platform so that the EMA Eligibility and Letter of Intent forms can be uploaded. The information uploaded to the platform is the same provided through IRIS.

The notification should include a request for access to the HTA IT Platform and the name, EU Login account username, and email address of the contact person responsible for the JCA for the particular medicinal product.

Access to the HTA IT Platform

The HTA IT Platform is used for submitting information related to the JCA process.

Following receipt of the notification, the HTA Secretariat sends an upload link and provides instructions on how to upload a copy of the Eligibility and Letter of Intent forms downloaded from IRIS.

The upload link is specific to one product and one Letter of Intent. Therefore, if a health technology developer plans to upload several Letters of Intent, a separate upload link must be requested for each Letter of Intent. The Secretariat acknowledges successful submission of the forms by email.

Handling of Sensitive Information

The early notification email should not contain sensitive information about the product or applicant.

The relevant information should instead be uploaded through the HTA IT Platform. The European Commission also explains that product-specific communication in the JCA context takes place through the secure HTA IT Platform, following the required access process.

Keeping the Information Up to Date

Health technology developers are also reminded to provide updates related to the planned marketing authorisation application.

If there are changes to the intended marketing authorisation application submission date, the developer should provide the relevant update to the HTA Secretariat through the HTA IT Platform when the application has been identified as falling under Article 7 of the HTA Regulation.

Developers should also inform the HTA Secretariat if they decide not to pursue the application. In addition, if a product that was not originally expected to be subject to JCA becomes subject to JCA because of a delay in the planned marketing authorisation application submission to EMA, the developer should contact the HTA Secretariat.

How the JCA Process Starts

For a relevant medicinal product, the health technology developer submits the marketing authorisation application to EMA and provides the required information to the HTA Secretariat.

The EMA also informs the HTA Secretariat about the submission of the marketing authorisation application. The JCA process formally begins when an assessor and co-assessor are appointed, after which the HTA Secretariat informs the health technology developer about the start of the process.

Communication During the JCA

Product-specific communication related to the JCA takes place through the secure HTA IT Platform. The platform is not a general messaging platform and access is granted by the HTA Secretariat.

For a new product subject to JCA, health technology developers should notify the HTA Secretariat by email about their intention to upload documents and request the relevant access link.

The access link is personalised and product-specific. Only the person who requested access can use it, and a separate link is required for each product subject to JCA. If early information has already been submitted for a product, the same access or upload link can be used for further information.

A More Prepared Approach to JCA

The updated early information process brings together the identification of products potentially subject to JCA, submission of information through EMA's IRIS portal, notification to the HTA Secretariat, access to the HTA IT Platform, and continued communication during the JCA process.

For health technology developers, identifying JCA applicability early and providing the required information through the established process supports preparation for the joint clinical assessment. The JCA eligibility checker provides an additional way to check whether a medicinal product is potentially within the scope of the HTA Regulation and helps developers start preparing at an early stage.