How do you prepare for the Joint Clinical Assessment under the EU HTA Regulation when the assessment scope is fixed only shortly before the dossier deadline?

The Joint Clinical Assessment evaluates the clinical evidence once at EU level, in parallel with the centralized authorization. Added benefit, price and reimbursement remain decisions for each member state.

• The cut-off dates are in Art. 7(2) of Regulation (EU) 2021/2282: since January 12, 2025 for new active substances for cancer and for advanced therapy medicinal products, from January 13, 2028 for orphan medicinal products, and from January 13, 2030 for all other medicinal products in the centralized procedure.
• The assessment scope sets the patient population, intervention, comparators and health outcomes (Art. 8(6)). Under Art. 10(2) of Implementing Regulation (EU) 2024/1381, it is finalized no later than ten days after the CHMP adopts its list of questions.
• The dossier is due 100 days after the Commission's first request, or 60 days in accelerated procedures (Art. 12(2) of the Implementing Regulation), and the deadline falls at least 45 days before the planned CHMP opinion (Art. 10(1) of the Regulation).
• The report describes relative effects and their certainty and contains no value judgment on added benefit (Art. 9(1)). Member states give it due consideration and do not request again at national level any data already submitted at EU level (Art. 13(1)).
• Class IIb and III medical devices and class D in vitro diagnostics only fall under the procedure if the Commission selects them, at least every two years, using criteria such as unmet medical need or being the first device in a new category (Art. 7(4)). The procedural rules for assessing selected devices are set out in Implementing Regulation (EU) 2025/2086; the selection itself is made by a separate implementing act.