A consultation has been launched today on a draft Commission Implementing Regulation (EU) that lays down detailed procedural rules for the preparation and update of joint clinical assessments of medicinal products for human use at the Union level, as required by Regulation (EU) 2021/2282 on health technology assessment.
The key aspects covered by this Regulation include:
- Cooperation and exchange of information with the European Medicines Agency during joint clinical assessments.
- Interaction and timing with the Coordination Group, its subgroups, health technology developers, patients, clinical experts, and other relevant experts.
- Procedural rules for selecting and consulting stakeholders, patients, clinical experts, and other relevant experts.
- Templates and formats for dossiers, joint clinical assessment reports, and summary reports.
- Deadlines and procedures for various stages, such as finalising the assessment scope, submitting dossiers, preparing draft reports, and considering updates.
- Rules for handling changes to therapeutic indications, re-initiating assessments, and updating assessments.
- Requirements for correspondence and use of the HTA IT platform.
- Provisions for confidentiality requests and processing of personal data.
This draft act is open for feedback for 4 weeks (until the 2nd of April), which will be considered for finalising the initiative.
Why does this matter?
This draft document provides more detail than what was previously available about how the EU aims to ensure a uniform approach, high scientific quality, transparency, and timely patient access to health technologies through the joint clinical assessment process. Once feedback has been considered the document will be finalised; it is set to apply from 12 January 2025, marking the implementation of the joint clinical assessment framework under Regulation (EU) 2021/2282.
Additional resources
Keep an eye out for our articles exploring EU HTA in more detail; we have one coming up soon titled ‘What considerations companies / manufacturers require for their EU HTA submissions’.
Plus, view our latest EU HTA webinars below:
Sources:
- https://www.linkedin.com/posts/accessus-health-gmbh_europeancommission-implementingact-jointclinicalassessments-activity-7170751146783936512-trWq/?utm_source=share&utm_medium=member_desktop
- https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13708-Health-technology-assessment-joint-clinical-assessments-of-medicinal-products_en