The Joint Clinical Assessment has changed what a European launch dossier has to prove. What it has not changed is when that proof has to be designed — and by the time a pivotal trial is running, most of the choices that decide a JCA outcome have already been made. The Joint Scientific Consultation, established by Regulation (EU) 2021/2282, is the mechanism that lets developers test those choices with HTA bodies while they can still be changed.
What a JSC is, and what it is not
A JSC allows a health technology developer to obtain scientific consultation during the planning of clinical studies or clinical investigations, specifically on the information and evidence needs of a subsequent Joint Clinical Assessment. The subject matter is therefore evidence generation: comparator choice, relevant patient populations, endpoints that payers accept, and how indirect comparisons will be constructed if a head-to-head trial is not feasible.
It is not a negotiation and it does not pre-agree an outcome. The consultation is advisory; it does not bind the assessors who will later handle the JCA, and it says nothing about price. Its value is diagnostic — it tells you where your evidence plan and the expectations of European HTA bodies diverge, at a point when redesigning a trial arm is still possible.
The 2026 request windows
Requests can only be submitted during the request periods set out in the Annual Work Programme of the Member State Coordination Group on HTA. For 2026 these are:
- 7 January to 4 February 2026
- 1 to 29 April 2026
- 3 June to 1 July 2026
- 23 September to 21 October 2026
Each window feeds a defined schedule of briefing document deadlines and discussion meetings that run well into the following year. A request accepted from the autumn 2026 window, for example, leads to briefing document deadlines in the first quarter of 2027 and discussion meetings from May 2027 onwards. Planning backwards from a first-in-human or pivotal study start date is the only sensible way to use the calendar.
The mechanics catch people out
Requests are submitted through the secure HTA IT Platform, using the dedicated templates for medicinal products or for devices and IVDs. Access is not automatic: the developer must first contact the HTA secretariat by email, naming a contact person and their EU Login account, and receive an access link in return. That initial email must contain no commercially sensitive information — all product-specific material belongs on the platform. Companies that leave this until the request window opens usually miss it.
Running it in parallel with EMA
A parallel consultation with the European Medicines Agency is available for medicinal products, with its own briefing document template. This is where the exercise earns its keep. Regulators and HTA bodies do not always want the same comparator or the same endpoint, and discovering that at the point of assessment is expensive. A parallel consultation surfaces the tension early and produces separate feedback from each side, allowing the development plan to serve both a marketing authorisation and a reimbursement decision.
How PQRA helps
- Assessing whether a JSC is warranted and which request window fits the development timeline
- Preparing request forms and briefing documents to the required templates
- Building the comparator, endpoint and PICO rationale that HTA bodies will scrutinise
- Coordinating parallel EMA and HTA consultations within a single evidence strategy
- Translating consultation outcomes into protocol amendments and into national reimbursement planning in Greece
Evidence that satisfies a regulator does not automatically satisfy a payer. Contact PQRA to discuss your evidence-generation strategy and European HTA readiness.
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