The European Union has taken a major step toward harmonising how new medicines are evaluated across its member states, with the formal launch of Joint Clinical Assessments (JCAs) under Regulation (EU) 2021/2282 — the EU’s Health Technology Assessment (HTA) Regulation europa. These assessments are designed to provide a shared scientific analysis of clinical evidence on new health technologies, helping national authorities make faster and more consistent decisions about which treatments to fund and reimburse. Rather than each country independently reviewing the same drug, the EU framework pools expertise through a coordinated process overseen by the Member State Coordination Group on Health Technology Assessment (HTACG).

From 12 January 2025, new medicines for the treatment of cancer and advanced therapy medicinal products became subject to joint clinical assessments. europa This means that pharmaceutical companies seeking market approval for these therapies must now engage with both the European Medicines Agency (EMA) and the HTA secretariat simultaneously. When submitting a marketing authorisation application to the EMA, health technology developers must at the same time submit the summary of product characteristics and the clinical overview of the application to the HTA secretariat europa, which uses that information to define the scope of the joint assessment.

Communication between developers and EU regulators during the JCA process is managed through a secure digital platform. All product-specific communication in the context of a joint clinical assessment takes place on the secure HTA IT platform europa, though access must be requested in advance via email to the HTA secretariat. Developers are assigned personalised, product-specific access links, and the system is designed to protect commercially sensitive information throughout the evaluation process.

The initiative marks a significant shift in how Europe approaches the relationship between market authorisation and health technology assessment. By conducting clinical evaluations jointly at the EU level, the framework aims to reduce duplication, speed up patient access to innovative therapies, and ensure that national reimbursement decisions are grounded in the same high-quality evidence base.