Case study · Rare disease · policy and access
A fast-track dossier for China’s rare disease catalogue
Two weeks to confirm the submission route, assemble the disease evidence package and coordinate an eligible Chinese sponsoring organisation.
What they asked
Inclusion in China’s Rare Disease Catalogue changes what is possible for a disease: it shapes diagnosis pathways, access and the terms on which a therapy can later be reimbursed. The catalogue update process was open, the timeline was short, and GRIN-NDD needed a China-side dossier prepared to the form the process expects.
What we did
- Confirmation of the submission route and procedural requirements
- Preparation of the disease evidence package
- Coordination with an eligible Chinese organisation or NGO
- Support for the presentation and submission within the applicable timeline
How it ran
Confirm the route before writing anything
Catalogue submissions are not open to any applicant, and the procedural requirements are not published as a single document. The first work was establishing which route applied and what it demanded.
Assemble the evidence package
Epidemiology, clinical description, diagnostic pathway and unmet need, structured to the expectations of the reviewing bodies rather than to a European dossier template.
Find the sponsor
Where the route requires a Chinese organisation or NGO to carry the file, we coordinated that relationship — the step that most foreign applicants discover too late.
Deliver inside the window
The engagement ran on an accelerated cycle to meet the submission deadline, with rapid input and review loops on all sides.
Outcome
- The submission route confirmed, with its procedural requirements documented.
- A complete disease evidence package prepared in the expected form.
- An eligible Chinese sponsoring organisation coordinated.
- The file presented within the process window.
This work supports the process of submitting a disease for consideration. Acceptance, prioritisation and inclusion are decided entirely by the relevant Chinese authorities and expert bodies.
What it taught us
Access work in China is often procedural rather than scientific. Knowing which door the file goes through, and who is allowed to carry it, is most of the engagement.
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