HTA Regulation - European Commission Publishes Implementing Regulation containing Procedures for Joint Scientific Consultations on Medicinal Products
- 19/12/2024
- News
The European Commission publishes today the fourth of six Regulations implementing the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU) (see, Van Bael & Bellis Life Sciences News & Insights of 15 December 2021 and Van Bael & Bellis Life Sciences News & Insights of 22 December 2021) (the HTA Regulation).
The fourth Implementing Regulation sets out procedural rules for the "joint scientific consultations” to be carried out by the Member State Coordination Group on HTA with medicine developers on their development plans for a given medicinal product for human use. Those consultations are intended to facilitate the generation of the information, data, analyses and other evidence that are likely to be required for the subsequent joint clinical assessment of that medicinal product (see, Articles 16-21, HTA Regulation) (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 and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level”; the Fourth Implementing Regulation – see, attached copy).
The Fourth Implementing Regulation governs in particular (i) the submission of requests from medicine developers; (ii) the selection and consultation of stakeholder organisations and patients, clinical experts and other experts; and (iii) cooperation with the European Medicines Agency (EMA) when a medicine developer requests a joint scientific consultation to be carried out in parallel with EMA’s scientific advice process.
As the HTA Regulation will apply on 12 January 2025, the Fourth Implementing Regulation will apply on the same date. The first three Implementing Regulations were published on, respectively, 25 May 2024, 18 October 2024 and 28 October 2024 (see, Van Bael & Bellis Life Sciences News & Insights of 22 October 2024 and Van Bael & Bellis Life Sciences News & Insights of 28 October 2024).
