Every market. Every pathway. One source of truth.
Authority-cited country profiles for 15 markets, including the only structured database of unlicensed medicine pathways. Reviewed quarterly by named regulatory contributors.
Free to browse · No credit card · How we verify
Country regulatory profiles
Identical structure across 15 markets — authorities, MA pathways, fees, timelines, MAH/RP requirements, post-approval lifecycle. Every figure is sourced.
Unlicensed medicine pathway database
Named patient supply, compassionate use, and emergency import — with legal basis, approval authority, documentation, and timeline. The only structured database of its kind.
Side-by-side country comparison
Benchmark timelines, fees, reliance pathways, and local-presence requirements across up to three markets. Replaces the spreadsheet you've been maintaining.
See for yourself
A profile you can interrogate, not just read
Every page is structured the same way: authority, pathways, fees, timelines, MAH and RP requirements, post-approval, supply chain, pricing. Every figure is linked to its primary source. Every section carries a freshness and confidence indicator.
- Linked sources at section level — never a free-floating claim.
- Tracks fee revisions, pathway changes, and lifecycle reform.
- Named contributor on every page — full credentials disclosed.
United Kingdom
MHRA · Europe
IRP timeline
60–110 days
IRP fee
£35,305
English subs
Accepted
eCTD
v3.2.2 / v4
Reliance
8 reference agencies
Local rep
Not required (IRP)
Sources
MHRA International Recognition Procedure (Jan 2024) · MHRA Fees 2024-25 · MHRA Submissions portal v3.1 spec.
15 markets, identical structure
From the FDA to PMDA — side-by-side comparable.
Editorial standards
Built like a regulatory publication, not a SaaS dashboard
Tier-1 source hierarchy. Quarterly full audits. Named contributors with disclosed conflicts of interest. Every claim is linked to its primary source.
Quarterly full audit
Every country profile re-verified end-to-end against primary sources at minimum every 90 days.
Tier-1 source hierarchy
Authority publications first. Consultancy and academic sources only ever as triangulation.
Named contributors
Every profile carries a contributor name and credentials. We do not anonymise authorship.
| Criterion | 🇬🇧 UK | 🇪🇺 EU | 🇺🇸 US |
|---|---|---|---|
| Lead pathway | IRP | Centralised | NDA |
| Approval (days) | 60–110 | 210 | 180–360 |
| English subs | Yes | Yes | Yes |
| Local rep | Not required | MAH in EU/EEA | US agent |
| Reliance | 8 agencies | — | — |
| HTA | NICE/SMC | Member-state | — |
Stop maintaining the spreadsheet
Side-by-side comparison across markets
Pick two or three countries. Get every criterion an RP or QP actually files against — timelines, fees, MAH residency, local responsible person, GMP inspection, accelerated pathways, post-approval framework, HTA. Save the view, share it.
Simple pricing
Browse free. Upgrade for depth.
Professional
$49/mo
Full unlicensed pathways, comparison tool, unlimited AI, branded PDF export, alerts.
See Pro detailsStop second-guessing the regulatory map
Country profiles you can interrogate. Pathways you can compare. An assistant grounded in the same source-cited dataset.