Raft of new procedural rules and guidance documents published in lead up to EU HTAR
As outlined in the newly adopted HTACG Annual Work Programme 2025, several new guidance documents and procedural rules have been released and are now accessible on the European Commission's platform. These resources provide stakeholders with critical tools to prepare for the full implementation of the European Union's Health Technology Assessment Regulation (EU HTAR).
Set to take effect in January 2025, EU HTAR will introduce the joint clinical assessment (JCA) process, a key initiative aimed at harmonizing health technology assessment (HTA) practices across EU Member States. By expediting access to innovative health technologies and addressing inefficiencies in evaluating clinical evidence, the regulation seeks to create a more streamlined, transparent and equitable system that promotes consistency and high-quality amongst HTA bodies. To successfully engage with the JCA framework, stakeholders must familiarize themselves with the newly established rules, procedures, and guidance to ensure timely and consistent assessments that support regulatory decisions and equitable patient access.
Several implementing acts have already been ratified, laying the legal groundwork for JCAs of medicinal products, information exchange with the European Medicines Agency (EMA), and procedures for managing conflicts of interest. Still in development are guidelines for joint scientific consultations (JSCs) on medicinal products, medical devices, and in vitro diagnostic medical devices, which are currently being finalized following public consultation. Additionally, the act for the JCA of medical devices and in vitro diagnostic medical devices remains under preparation as a draft.
The newly available guidance and procedures include:
Guidance on the scoping process: Supports Member States in preparing the scoping process and formulating national PICOs, while also assisting assessors and co-assessors in developing the assessment scope by detailing the methods and key steps involved. The guidance covers the process from PICO survey proposals to informing health technology developers (HTDs) about PICOs, addressing data presentation and the influence of study statistical plans on evidence assessment in JCA reports.
Guidance on filling in the JCA dossier template – Medicinal products: The European Commission published the final JCA submission template in May 2024, outlining the required information and its structured presentation. This document provides guidance to HTDs on completing the template for the dossier.
Guidance for the selection of medicinal products for JSCs: The guidance addresses the eligibility and selection criteria for JSC of medicinal products under both the Health Technology Assessment Coordination Group (HTACG) and Parallel HTACG/EMA formats. The document aims to assist HTDs in preparing JSC requests and provides direction for the JSC Subgroup (JSC SG) in the selection process.
Briefing document template for Parallel HTA Coordination Group HTACG/ EMA Joint Scientific Consultation (JSC) for Medicinal Products (MP): This template provides a standardized format for briefing documents, facilitating efficient communication and streamlined consultation processes.
Briefing document template for JSC for Medicinal Products: Similar to the Parallel HTACG/EMA template, this document is designed specifically for HTACG-only JSCs, ensuring consistency in the submission process.
Procedural guidance for JSCs on Medicinal Products: This document outlines the procedural steps and timeline for conducting JSCs, serving as a key reference for HTDs and stakeholders. It details processes for both HTACG JSC and Parallel HTACG/EMA JSC formats, with the latter's procedures coordinated in agreement with the EMA secretariat.
Guidance on the appointment of assessors and co-assessors for JCA and JSC: The guidance outlines the procedure for appointing assessors and co-assessors, specifying minimum requirements for their roles in JCAs and JSCs for medicinal products, medical devices, and in vitro diagnostic devices.
Procedural guidance for JCA medicinal products: Describes the rules, procedures, and timelines for JCAs of medicinal products, providing a comprehensive framework for stakeholders to follow.