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.
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.
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.
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.
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.
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).
February 2025
JSC Request period for medicinal products only
Between 3 February to 3 March 2025, manufacturers may submit a request for Joint Scientific Consultation for medicinal products, to obtain advice on evidence needs for a subsequent JCA. This is the first possible submission period of two periods in total in 2025 and would lead to the start of the JSC procedure in one of three available consultation slots (beginning in June, July or September 2025).
March 2025
JSC Request period for medicinal products only
Between 3 February to 3 March 2025, manufacturers may submit a request for Joint Scientific Consultation for medicinal products, to obtain advice on evidence needs for a subsequent JCA. This is the first possible submission period of two periods in total in 2025 and would lead to the start of the JSC procedure in one of three available consultation slots (beginning in June, July or September 2025).
