EU Implementing Regulation 2024/1381 Sets the JCA Dossier and Scoping Rules

Regulation (EU) 2021/2282 requires joint clinical assessments for in-scope medicines and leaves detailed procedure to implementing acts. Implementing Regulation (EU) 2024/1381 sets out how the Coordination Group, its joint clinical assessment subgroup, health technology developers, patients and clinical experts interact, including timing. Its annexes contain templates for the dossier and for the assessment reports.

The regulation is organised around the main stages of an assessment. Article 2 concerns the information used to develop the assessment scope, and Articles 9 to 12 cover the assessment scope proposal, its finalisation, a scope explanation meeting and the draft reports. Article 16 deals with changes to the therapeutic indication during the process. Secondary sources report that the regulation has applied since 12 January 2025, the date on which joint clinical assessments began for cancer medicines and advanced therapy medicinal products.

Scoping defines the populations, interventions, comparators and outcomes (PICO) that the assessment must address. The process starts from the therapeutic indication proposed by the developer, and Member States are surveyed for the PICO elements they need for their national decisions. These are then consolidated into the assessment scope, which can contain several PICO combinations.

Commentary on the draft act criticised the limited role of developers in scoping. In the final text, according to secondary analysis, developers may request a scope explanation meeting rather than waiting to be invited. The exact timing of scope finalisation relative to the regulatory review is reported differently across secondary sources, and should be confirmed against the Official Journal text. If the indication changes during the process, Article 16 allows the subgroup to decide whether the assessment can continue or must return to an earlier stage, which may require a revised scope and dossier.

A key practical consequence of multi-country scoping is that the assessment scope can include comparators that are standard of care in some Member States but not in others. Developers therefore need evidence, or a transparent explanation of the absence of evidence, for each requested comparison. Where direct evidence is lacking, indirect treatment comparisons are commonly used, and their assumptions and limitations will be described in the assessment report.

The developer must submit a dossier that follows the annexed template and presents the evidence for each PICO in the assessment scope. According to the regulation text and the Commission’s factsheet, the standard deadline is 100 days from notification of the Commission’s request, which can be shortened to 60 days in certain situations. The Commission’s factsheet states that in every case the dossier must be submitted no later than 45 days before the expected opinion of the EMA Committee for Medicinal Products for Human Use (CHMP).

The 100-day window was extended from 90 days in an earlier draft, according to consultancy analysis of the consultation. Because joint assessments run in parallel with the marketing authorisation procedure, dossier preparation must begin well before scoping is final, using expected PICOs as a guide.

Developers should prepare for a dossier that may need to cover comparators and populations not studied in pivotal trials, often through indirect comparisons. Early PICO simulation, using national HTA experience, helps identify evidence gaps while there is still time to address them. Developers should also plan internal governance so that the dossier can be completed within the 100-day or shorter window.

The first joint clinical assessment report, published by the Commission on 9 June 2026, provides a practical example of how evidence against each PICO is presented. Pubrica’s summary is for information only and does not replace the legal text or guidance issued by the Commission or the Coordination Group.

Developers should also consider how the joint dossier relates to national submissions. Several Member States have adapted their national procedures so that companies can refer to information already provided in the joint dossier, reducing duplication. Germany, for example, amended its procedural rules in 2025 so that companies may refer to the EU dossier in their national benefit dossier. National requirements that go beyond the joint scope still need to be addressed separately.