COMMISSION IMPLEMENTING REGULATION (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments
COMMISSION IMPLEMENTING REGULATION (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices
COMMISSION IMPLEMENTING REGULATION (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament andof the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union levelCOMMISSION IMPLEMENTING REGULATION (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament andof the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level
COMMISSION IMPLEMENTING REGULATION (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups
COMMISSION IMPLEMENTING REGULATION (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices
COMMISSION IMPLEMENTING REGULATION (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessmentsCOMMISSION IMPLEMENTING REGULATION (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments
Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) entered into force in January 2022 and will be phased in from January 2025 (information can be found here). The purpose of the Regulation is to increase the quality of OST in the European Union and to contribute to the improvement of patients' access to innovative technologies in the field of health care, such as medicinal products and medical devices paid for by public funds. It aims to harmonize the health technology assessment procedures of innovative drug therapies entering the European Union market in different countries, as well as to reduce the administrative burden for health technology developers.
The National Council on Prices and Reimbursement of Medicinal Products carries out a Health Technology Assessment of medicinal products, on the basis of Art. 259, paragraph 1, item 6 of the MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT (SG, No. 102 of 2018, in force from 01.01.2019) and art. 1, item 8 and Chapter Six of the ORDINANCE ON THE TERMS, RULES AND PROCEDURE FOR REGULATION AND REGISTRATION OF PRICES FOR MEDICINAL PRODUCTS (SG, No. 26 of 2019, in force from 01.04.2019)
Health Technology Assessment summary reports: Pursuant to Art. 7, para. 6 of the ORDINANCE ON THE TERMS, RULES AND PROCEDURE FOR REGULATION AND REGISTRATION OF PRICES FOR MEDICINAL PRODUCTS (SG, No. 26 of 2019, in force from 01.04.2019). The Council publishes on its website the summary reports on the Health Technology Assessment only after written consent has been provided by the respective Marketing Authorization Holder of the evaluated medicinal product.
