JCA Dossier Support and JSC
Dossier development
Combining proactive preparation with deep expertise in HTA dossier development, we support efficient delivery of JCA-ready submission packages.
Anticipatory Evidence Generation
SLRs of clinical, safety and HRQOL data
Indirect comparison
Anticipatory dossier drafting
Anticipatory Evidence Generation
Update SLRs
Finalise indirect treatment comparisons
Finalise JCA dossier
What is JSC?
Joint Scientific Consultation (JSC) was introduced under the HTAR framework for manufacturers to obtain early advice during the JCA process.
JSC can be requested in parallel with the European Medicines Agency (EMA), enabling manufacturers to gain input from both regulators and HTA bodies across EU member states to support market authorisation and reimbursement decision-making.
Early engagement with JSC supports informed planning of pivotal trials as well as guidance on the evidence packages required for JCAs and national HTA submissions.
How does the JSC process work?
Applications are limited to the request periods; therefore, engagement should be anticipated early to ensure readiness to apply at the optimal time.
Manufacturers must respond to some points in writing ahead of the JSC meeting, where the outstanding issues are discussed.
The JSC procedure takes approximately 4.5 months following submission of the briefing package.
How to get selected for JSC?
As the number of JSC slots is expected to be lower than the number of eligible requests, particularly in the first few years, products will be selected based on a series of selection criteria:
Unmet medical need
First in class
Impact on patients, public health or healthcare systems
Significant cross-border dimension
Major union wide added value or union clinical research priority
To be eligible for JSC a medical product must meet the following criteria:
- being likely to be the subject of JCA
- clinical studies and clinical investigations are still in the planning stage.
Strategic considerations for JSC
JSCs can streamline preparation for JCA and ensure that clinical studies generate JCA-ready evidence, however engagement requires considerable time and resource investment, so it is critical to assess whether it is the right route for your product:
A critical component of JSC is development of the list of questions, ensuring they are strategically tailored and elicited at the appropriate stage of development to generate actionable insights for evidence generation.
Although JSC recommendations are not legally binding, manufacturers are expected to justify any deviations from the advice received, making well-positioned questions essential.
Drawing on our experience in national scientific advice, Symmetron can provide strategic guidance throughout the JSC process, and hands-on support across all stages, to maximise the value of engagement and translate advice into practical steps that support successful JSC outcomes.
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London, EC2M 4PL, UK
