Country regulatory profiles
Identical structure across 41 markets — authorities, MA pathways, fees, timelines, MAH/RP requirements, post-approval lifecycle. Every figure is sourced.
MARKETS41PROFILES VERIFIED41/41PATHWAYS INDEXED150RELIANCE PATHWAYS34ICH MEMBER STATES31ENGLISH SUBMISSIONS31AUDIT CADENCEQUARTERLYSOURCESTIER-1 ONLY
MARKETS41PROFILES VERIFIED41/41PATHWAYS INDEXED150RELIANCE PATHWAYS34ICH MEMBER STATES31ENGLISH SUBMISSIONS31AUDIT CADENCEQUARTERLYSOURCESTIER-1 ONLY
For RPs, QPs, RA & QA teams
Every market. Every pathway. One source of truth.
Authority cited profiles for 41 markets. The only structured database of unlicensed pathways.
41Markets
150Pathways
34Reliance routes
§ 01 — Capabilities
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.
§ 02 — A profile, dissected
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.
🇬🇧
UpdatedUnited 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.
§ 03 — Coverage
41 markets, identical structure
From the FDA to PMDA — side-by-side comparable.
§ 04 — Editorial standards
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 | IRPIRP | Centralised | NDANDA |
| Approval (days) | 60–110 | 210 | 180–360 |
| English subs | Yes | Yes | Yes |
| Local rep | Not required | MAHMAH in EU/EEA | US agent |
| Reliance | 8 agencies | — | — |
| HTAHTA | NICENICE/SMCSMC | Member-state | — |
Lead pathway
- 🇬🇧 UKIRPIRP
- 🇪🇺 EUCentralised
- 🇺🇸 USNDANDA
Approval (days)
- 🇬🇧 UK60–110
- 🇪🇺 EU210
- 🇺🇸 US180–360
English subs
- 🇬🇧 UKYes
- 🇪🇺 EUYes
- 🇺🇸 USYes
Local rep
- 🇬🇧 UKNot required
- 🇪🇺 EUMAHMAH in EU/EEA
- 🇺🇸 USUS agent
Reliance
- 🇬🇧 UK8 agencies
- 🇪🇺 EU—
- 🇺🇸 US—
HTAHTA
- 🇬🇧 UKNICENICE/SMCSMC
- 🇪🇺 EUMember-state
- 🇺🇸 US—
Stop maintaining the spreadsheet
Side-by-side comparison across markets
Pick two or three countries. Get every criterion an RPRP or QPQP actually files against — timelines, fees, MAHMAH residency, local responsible person, GMPGMP inspection, accelerated pathways, post-approval framework, HTAHTA. Save the view, share it.
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Stop second-guessing the regulatory map
Country profiles you can interrogate. Pathways you can compare. An assistant grounded in the same source-cited dataset.