Data sources & methodology

Our intelligence platform profiles are built from public regulatory and patent records, not proprietary commercial databases (Cortellis, Citeline, etc.) in v1.

Regional coverage (US, EU, APAC)

NovaPharmaNews is organised into three editions: United States (us), Europe (eu), and Asia–Pacific (apac). The APAC edition covers the full Asia–Pacific market (e.g. Japan, China, Australia, India, Korea, and ASEAN), not separate country sites.

On drug profiles, country/regulator detail appears under regulatory_status keys (US, EU, AU, JP, CN). Those keys describe which regulator sourced the fact; they are not additional site regions.

United States (Wave 1)

• FDA Drugs@FDA (openFDA) — drug applications, INNs, sponsors
• SEC EDGAR — public company identifiers and filings metadata
• ClinicalTrials.gov — US interventional trials and pipeline linkage
• USPTO PatentsView — US patents (pharma CPC classes A61K / A61P)

Asia-Pacific (Wave 3)

• PBS Schedule — Australian listed medicines (maps to TGA ARTG context; CC BY 3.0 AU)
• PMDA — English approval review report tables (Japan)
• NMPA — China regulatory announcements + ClinicalTrials.gov China trials (NIH public domain for trials)
• ClinicalTrials.gov — APAC facility-location interventional trials

European Union (Wave 2)

• EMA medicines data — EU marketing authorisations, INNs, MAH names (Re-use Notice — attribution required)
• GLEIF — LEI enrichment for EU marketing authorisation holders (public domain)
• EU CTIS — EU clinical trials public search API
• EPO Open Patent Services (EP patents) — ingest implemented; pending EPO developer account approval. EP rows are not published until credentials are active.

What we are not

• Not a substitute for official FDA, EMA, EPO, or USPTO publications
• Not medical or legal advice
• Not verified or endorsed by manufacturers unless a separate sponsored program says so

Attribution & updates

Each field on an entity profile is intended to carry machine-readable source attribution in our database. Pages show a human-readable disclaimer and last-updated timestamp where available. Patent expiry dates on EP/US rows may be estimates unless sourced from Orange Book or official PTA/PTE data.

Engineering registry (source keys, licenses, publication checklist): docs/data-source-licenses.md. Operational runbook: docs/entity-go-live.md.

Contact

Report a factual error on an entity page via contact — include the profile URL and the primary source that contradicts our data.