With the Joint Clinical Assessment (JCA) procedure running in parallel to the EMA regulatory approval, companies will have to prepare well in advance for tight timelines, with short turnaround times.

Starting already at the time of the regulatory filing, companies will then have to provide the European Commission HTA Secretariat with relevant information for the assessment, including the summary of product characteristics and the clinical overview section of the Marketing Authorization -Application (MAA).

In the time before the start of JCA, and in the first months of the JCA, During this time companies will not be made aware of the scope (i.e. the comparators) of the assessment, — and only at the latest 10 days after the first EMA clock-stop will companies be informed about the JCA scope. After this When the clock starts running, companies will have only 100 calendar days to prepare their dossier, and submit it, at the latest 45 days prior to the expected date of CHMP opinion. A clear understanding of each process step across teams and anticipating and preparing strategies for likely scenarios will be important for increased chance of success (alternatively: “to navigate the risks”).

Managing tight timelines: Given the tight timelines, and limited opportunities to discuss e.g. relevant comparators, companies will have to prepare for different PICO scenarios and ensure good collaboration between regulatory and market access teams. Setting the right expectations and clear communications around limitations in available evidence will also be a key success factor. It will also be important to have a clear understanding of the role of experts (i.e. clinicians and patients) who will be involved in a systematic manner throughout the assessment, by providing input on the PICO(s), and the draft report.

Seeking early advice is key: With the limited opportunities for interactions in JCA, the opportunities for early dialogue in both national scientific advice procedures and Joint Scientific Consultations (JSC) become even more important. The JSC slots will however also be limited, and the demand for these advice meeting is expected to by-far surpass the number of meetings that can be offered in 2025. Oncology products and Advanced Therapy Medicinal Products (ATMPs) are currently prioritised for JSCs, and when slots are limited, applicants will be prioritised according to criteria such as unmet medical need, whether the product is first in class or the potential impact on patients, public health or healthcare systems.