Navigating the EU joint clinical assessment process: key considerations for manufacturers of ATMPs and oncology medicines

The European Parliament and Council of the European Union adopted Regulation 2021/2282 on Health Technology Assessment on December 15, 2021. As of January 12, 2025, advanced therapy medicinal products and oncology medicines seeking marketing authorization from the European Medicines Agency will undergo a single, coordinated EU-wide HTA process, known as Joint Clinical Assessment. The aim of this article is to lay out some of the key considerations for manufacturers as they move closer to the introduction of the European Union Joint Clinical Assessment (JCA) process in 2025, accepting that some remaining procedural uncertainties persist. I will explore what type of evidence is needed to meet the JCA requirements and steps that manufacturers can consider taking to ensure their evidence will meet the necessary quality standards. The latter includes, but is not limited to, (i) adherence to the JCA methodological guidelines, (ii) the importance of proactively addressing known HTA evidence challenges, (iii) taking full advantage of opportunities to validate their evidence plans via the Joint Scientific Consultation Process, (iv) allowing sufficient time to generate the necessary evidence to put together a JCA submission, (v) putting together a place a plan of action to achieve this within tight time constraints and (vi) familiarization with the procedural rules for assessing and managing conflicts of interest. Further details on the JCA process will likely be disseminated by the European Commission over the next few months and manufacturers are encouraged to keep a keen eye out for these.

Please enter your email to access content Read now