EMA Prepares for Regulation on Health Technology Assessment
The Regulation on Health Technology Assessment (EU) 2021/228 which entered into force in January 2022 and applies as of January 2025, will govern the European cooperation between medicine regulators and HTA bodies. Under the new framework, EMA and HTA bodies will collaborate in the context of joint clinical assessments, joint scientific consultations, and the identification of emerging health technologies.
While aiming to improve the availability of innovative medicines and certain medical devices for patients in the EU, it will also ensure efficient use of resources and enhance the quality of health technology assessment in the EU by ensuring the sustainability of European cooperation. The establishment of the Member State Coordination Group on Health Technology Assessment, as provided by the regulation, and of a stakeholder network, will give a transparent and inclusive framework to facilitate continued collaboration between partners and reduce duplication of efforts for national HTA authorities and industry.
Transition period to January 2025
EMA and HTA organisations have established a new framework for Parallel EMA/HTA Scientific Advice for the period September 2023 until January 2025, when the HTA Regulation applies. During this transition period, developers can request the involvement of HTA bodies when applying for EMA scientific advice. The outcome of the procedure will be a scientific advice letter from EMA and individual written recommendations from participating HTA bodies. The selection criteria are available in the Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period.
Preparations are also continuing at EMA to pave the way for the implementation of the Regulation. The Agency has identified a number of priorities and opportunities for the next 15 months. These include defining a single evidence plan to facilitate development programmes, harmonising views on the strength of the evidence, and involving patients, clinical experts and other relevant experts in decision-making.
Source: European Medicines Agency
