NO ORPHAN CLAIMS
Source policy
Every material regulatory, clinical or market proposition should be independently traceable at the field where it appears.
Source hierarchy
- Primary: FDA, MHRA, GOV.UK, NICE, NHS bodies, AWTTC and AWMSG, SMC, HSC Northern Ireland, HPRA, NCPE, HSE, ClinicalTrials.gov and equivalent regulator or trial registries.
- Peer reviewed: journals, systematic reviews and published clinical evidence.
- Sponsor: developer or manufacturer announcements used for current pipeline and corporate development claims when primary confirmation is unavailable.
- Market signal: public clinic commentary, forums and vendor material used only to establish exposure or observed practice, never efficacy, quality or legality.
Market source map
| Market | Authorisation | Assessment and access |
|---|---|---|
| England | MHRA | NICE, NHS England and local commissioning or formulary sources |
| Wales | MHRA | NICE, AWTTC, AWMSG and NHS Wales sources |
| Scotland | MHRA | SMC, NHS Scotland and NHS board sources |
| Northern Ireland | MHRA | Department of Health, HSC and regional medicines sources |
| Republic of Ireland | HPRA or applicable European authorisation | NCPE, HSE and reimbursement scheme sources |
Market signal handling
Exposure classifications are editorial surveillance assessments, not prevalence estimates. Underlying observations should be timestamped and retained in the editorial ledger. Public records do not promote or link to unlicensed sellers. A market signal never supports a claim of efficacy, pharmaceutical quality, lawful supply or clinical appropriateness.
Absence statements
When a record states that no authorisation, assessment or access route has been identified, it links to the relevant official verification route. Absence statements are market specific, time bound and carry a last verified date.
Regulatory language
FDA Pharmacy Compounding Advisory Committee consideration is not FDA drug approval. NICE, AWMSG, SMC and NCPE make assessments or recommendations; they do not issue medicine marketing authorisations. Health service access is assessed separately from authorisation and national assessment.