OBJECTIVES: Since January 2022, the European Medicines Agency (EMA) has replaced the Parallel Consultation (PC) with Regulators and Health Technology Assessment Bodies (HTABs) with the Parallel EMA/European network for Health Technology Assessment (EUnetHTA) 21 Consortium. The Joint Scientific Consultation (JSC) represents a preparatory phase for the Joint Clinical Assessment (JCA) within the new EU-HTA regulation. Objectives of this study were to: i) compare the two processes; ii) gather information on their opportunities and challenges; iii) assess impact of the new JSC on preparing for the JCA.

METHODS: We conducted a pragmatic literature search on scientific databases (Pubmed and Embase, Econlit and Medline via PsychInfo–Ovid) from July 2018 up to June 2023 in the English language. A grey literature search was also performed to complement information on the new JSC.

RESULTS: The targeted search identified 150 publications, however only 15 were included in our review. The search identified limited evidence on JSC to allow for a full comparison. Main differences between the two procedures are the following: while PC allowed Health Technology Developers (HTDs) to seek advice before or after product availability on the market, for JSC clinical studies must be in the planning stage and should meet different eligibility criteria. Differently from JSC, the EMA-HTA PC included streamlined procedure based on EMA’s Scientific Advice timetables and an early dialogue working party (EDWP), a stable group with significant experience in ED. Compared to PC, within the JSC there is the chance to anticipate the PICO (Population, Intervention, Comparator, Outcomes) scoping, which represents the first step of JCA within the new regulation.

CONCLUSIONS: While pursuing Integrated Scientific Advice with the EMA and HTA bodies remains crucial, the value of JSC process is probably greater to optimise the evidence around clinical data. More studies from real cases are needed to provide evidence on JSC value.