Earlier today (03 July 2023) the European Medicines Agency released updated guidance on "Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period".
As a result of the agreement between the European Medicines Agency (EMA) and Health Technology Assessment bodies (HTAbs) to facilitate joint work in preparing scientific consultations under Article 16 of the HTA Regulation (HTAR), an interim consultation approach will be offered, referred as Parallel EMA/HTA body (HTAb) Scientific Advice.
The guidance aims to facilitate collaboration and communication between the two entities by establishing a framework for exchanging scientific information and expertise related to the development and assessment of medicinal products.
The guidance describes the timelines, process, and key factors involved in obtaining parallel scientific advice from both EMA and HTA bodies, so that decisions regarding new medicines are efficient and coordinated.
The Parallel EMA-HTAb Scientific Advice allows requests for parallel discussions during the interim period between the completion of EUnetHTA 2021 in September 2023 and the full implementation of the HTA regulation (HTAR) in January 2025.
By using an interim format, Regulators and HTAbs can continue to collaborate on parallel advice with high scientific quality, further fostering mutual understanding between the two entities, and providing HTAbs with a central point of coordination.
Parallel EMA/HTAb Scientific Advice utilizes Eudralink to exchange documents between the Applicant and the HTA Coordination Contact and IRIS for the Applicant and EMA to exchange documents.