The European Commission has updated its guidance on the submission of early information for joint clinical assessment (JCA) of medicinal products.
The update follows the European Medicines Agency’s publication of revised pre-authorisation guidance on 19 August 2026. The updated EMA guidance sets out how applicants and health technology developers should declare, in the Eligibility and Letter of Intent forms submitted through the EMA’s IRIS portal, whether their marketing authorisation application falls within the scope of the Health Technology Assessment Regulation and is therefore subject to JCA.
The updated Commission guidance explains the corresponding steps for health technology developers to provide early information to the HTA Secretariat and to access the HTA IT Platform.
At the same time, a new JCA eligibility checker is now available on the European Commission’s Health Technology Assessment webpage.
The tool (in the form of an EU survey) is designed to help health technology developers check whether a medicinal product is potentially within the scope of a JCA under the HTA Regulation. The aim is to provide a simple way for developers to be prepared and start preparing for the JCA at an early stage.
Excerpt from the official page. The original is authoritative.