Key update: June 2024
In our post "What is Joint Clinical Assessment (JCA) process and how will it impact your product launch?", we shared that starting on 12th January 2025, medicinal products under Article 7(2), point (a) of Regulation (EU) 2021/2282 will undergo Joint Clinical Assessment (JCA). Initially, this includes new active substances for cancer treatment and advanced therapy medicinal products. By 13th January 2028, all orphan medicinal products and by 13th January 2030, all other medicinal products under Article 7 will be included.
The scope of the JCA assessment is defined through PICOs (Population, Intervention, Comparator, Outcomes) development, which consolidates diverse needs from all member states into several PICOs. Once these PICOs are communicated to pharmaceutical companies, they have only 100 days to submit the JCA dossier. This deadline is especially challenging given the need to conduct systematic literature reviews (SLRs) on all of the PICOs.
The EMA’s guidance, published on 21st June 2024, instructs manufacturers who have a product indicated for the treatment of cancer or which are designated to be an ATMP on declaring their application’s scope concerning the HTA Regulation via the EMA Letter of Intent. The Member State Co-ordination Group on Health Technology Assessment also provided a document to help identify products subject to JCA from 2025.
Applicants must notify the HTACG secretariat at SANTE-HTA-JCA@ec.europa.eu, requesting access to the HTA IT Platform for uploading the EMA Letter of Intent. The email should include the health technology developer’s contact details linked to their EU Login account. Upon receipt, HTACG will provide an upload link and acknowledge the submission. Each product requires a separate upload link.
