October - November 2026
2027 HTACG Work Program prepared / adopted
HTACG adopts the 2027 Annual Work Program, outlining the strategic direction for EU-level HTA activities and the planned volume of JCAs and JSCs for the coming year.
June 2026
First EU JCA Report Published
HTACG endorses and publishes the first JCA report and summary report under the EU HTA Regulation, concerning Ojemda/tovorafenib for the treatment of pediatric low-grade glioma.
May 2026
Guiding Principles on Data Transparency Adopted
HTACG adopts and publishes guiding principles on data transparency, setting out expectations for the handling and publication of data in joint work under the EU HTA Regulation.
Updated Methodological and Procedural Guidance Published
HTACG publishes updated Q&A on methodological and procedural aspects of JCAs, alongside new guidance on data transparency and an FAQ document on the publication of JCA reports.
February 2026
HTACG 2025 Annual Report published
HTACG publishes its first annual report on the implementation of the EU HTA Regulation summarizing progress during 2025, including the launch of 13 JCAs and preparatory activities for medical device and IVD JCAs planned to start in 2026.
November 2025
HTACG Adoption of the Annual Work Program for 2026
Adoption of the 2026 Annual Work Program, outlining the strategic direction for the HTACG over 2026, and the planned number of JCAs and JSCs.
February 2025
PICO Exercise Outputs Published
HTACG publishes the outputs of PICO exercises conducted to test and refine the scoping process for medicinal-product JCAs, supporting the development and practical application of the guidance on PICO methodology.
January 2025
Launch of JCA for Cancer Medicines and ATMPs
The EU JCA process starts for new cancer medicines and advanced therapy medicinal products (ATMPs).
December 2024
Implementing Act on JSC
The EU JCA Implementing Act on Joint Scientific Consultations on Medicinal Products for Human Use is adopted. This act outlines the timelines and key procedural steps for manufacturers seeking guidance to support regulatory and HTA decision-making.
November 2024
HTACG Adoption of the Annual Work Program for 2025
Adoption of the 2025 Annual Work Program, outlining the strategic direction for the HTACG over 2025, and the planned number of JCAs and JSCs.
Guidance on filling in the JCA dossier template (medicinal products)
Guidance on filling in the joint clinical assessment dossier template is adopted, as a methodological supporting document to EU JCA Implementing Acts.
Guidance on steps and timeframe for JCA (medicinal products)
Guidance on procedural steps and timeframe for joint clinical assessments is adopted as a methodological supporting document to EU JCA Implementing Acts.
Guidance on the scoping process
Guidance on methodology for PICOs is adopted, providing detailed methodological guidelines and recommendations for the PICO scoping process.
October 2024
Implementing Act on Exchange of Information with EMA
The EU JCA Implementing Act on Exchange of Information with the European Medicines Agency is adopted, establishing procedural rules for seamless cooperation in information exchange between HTACG, EMA, and experts supporting joint clinical assessments.
Implementing Act on CoI Rules
The EU JCA Implementing Act on Conflict-of-Interest Rules is adopted, outlining rules for managing conflicts of interest among stakeholders involved in joint clinical assessments, ensuring assessments are conducted in an independent, impartial, and transparent manner.
May 2024
Implementing Act on JCA
The EU JCA Implementing Act on Joint Clinical Assessment of Medicinal Products for Human Use is adopted, outlining the timelines and key procedural steps for the joint clinical assessment of medicinal products.
January 2022
EU HTA Regulation Adopted
The EU HTA Regulation is adopted, establishing a new framework for Joint Clinical Assessments of new medicinal products across EU Member States and outlining a phased implementation plan for its adoption.