Guidance on Parallel EMA/HTA Body Scientific Advice Issued by Commission & EMA for the Interim Period

From September 2023 onwards, developers can request Parallel EMA-HTAb Scientific Advice on a rolling basis until the HTA regulation becomes applicable in January 2025.

This is to further facilitate the joint work of EMA and Health Technology Assessment bodies (HTAbs) in preparation of the joint scientific consultations under Article 16 of the HTA regulation, the parties involved have agreed to offer an interim consultation approach, referred to as Parallel EMA/HTA body (HTAb) Scientific Advice.

This parallel EMA/HTA body Scientific Advice for the interim period is provided solely on the initiative of individual HTA agencies in preparation for the application from 12 January 2025 of Regulation (EU) 2021/2282 on health technology assessment.

The EMA charges fees for this procedure, which are the same as for standard Scientific Advice/Protocol Assistance including the application of any fee incentives. The charging of fees by the HTAb side depends on the HTAbs participating and their national rules on whether fees are payable for their involvement.

For all submitted requests, the HTAb involvement coordinating body, the G-BA (Gemeinsamer Bundesausschuss / Federal Joint Committee, Germany), which will be referred to as the “HTA Coordination Contact” hereafter, facilitates a centralised HTA recruitment. The Applicant will be informed about occurring fees by the HTA Coordination Contact as soon as HTAb participation is confirmed.

Parallel EMA-HTAb Scientific Advice provides a single gateway for requests for parallel discussions during the interim period, facilitating the transition from the completion of EUnetHTA 2021 in September 2023 to the full application of the HTA regulation (HTAR) in January 2025.

The model facilitates scientific advice before the start of pivotal clinical trials on initial evidence generation for Marketing Authorisation Application/Reimbursement, and Post Licensing Evidence Generation (PLEG, only in conjunction with a request for discussion of pivotal trial design) and promotes optimal and robust evidence generation fit-for-purpose for both Regulators and HTAbs.

Both the European Commission and the EMA state that interactions between medicines’ developers, Regulators and Health Technology Assessment bodies to discuss the development plan at an early stage of a medicinal product’s clinical development means that robust evidence can be generated during pre-approval studies to meet the needs of respective decision-makers as efficiently as possible.

Document source: hta-body-htab-scientific-advice-interim-period_en.pdf