# Sources by Region — URLs & Access Notes

## 🇨🇳 China

| Source | URL | Notes |
|--------|-----|-------|
| CDE | https://www.cde.org.cn | Drug evaluation center. Search by product name or approval number. Chinese-language primary. |
| NMPA | https://www.nmpa.gov.cn | Final approval body. Drug approval database at https://www.nmpa.gov.cn/datasearch/home-index.html |
| chinadrugtrials | http://www.chinadrugtrials.org.cn | Mandatory IND registry. Search by drug name (CN or EN), sponsor, or CTR number. |
| ChiCTR | https://www.chictr.org.cn | WHO primary registry. Better English search interface. |
| ClinicalTrials.gov (CN) | https://clinicaltrials.gov | Filter: Country = China |
| CNKI | https://www.cnki.net | Chinese academic literature. Subscription required for full text. |
| Wanfang | https://www.wanfangdata.com.cn | Alternative to CNKI; strong biomedical coverage. |
| CNIPA | https://www.cnipa.gov.cn | Chinese patent authority. Search tool: https://pss-system.cponline.cnipa.gov.cn |
| SinoMed | https://www.sinomed.ac.cn | Chinese biomedical literature, open access. |

**Tips for China searches:**
- Always search both simplified Chinese and English terms
- CDE drug numbers follow format: 国药准字 + letter + 8 digits (e.g., 国药准字H20050001)
- CTR numbers (chinadrugtrials): CTR + YYYYNNNNNN format
- NMPA approval categories: 化药 (chemical), 生物制品 (biological), 中药 (TCM)

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## 🇺🇸 United States

| Source | URL | Notes |
|--------|-----|-------|
| Drugs@FDA | https://www.accessdata.fda.gov/scripts/cder/daf/ | Full NDA/BLA/ANDA history, labels, reviews |
| FDA CDER | https://www.fda.gov/drugs | IND policy, drug shortage, safety communications |
| FDA CBER | https://www.fda.gov/vaccines-blood-biologics | Cell/gene therapy, vaccines, blood products |
| Orange Book | https://www.accessdata.fda.gov/scripts/cder/ob/ | Patent & exclusivity listings for approved drugs |
| Purple Book | https://purplebooksearch.fda.gov | Reference biologics + biosimilar interchangeability |
| SEC EDGAR | https://www.sec.gov/cgi-bin/browse-edgar | Pipeline disclosures in 10-K, 8-K, 20-F filings |
| ClinicalTrials.gov | https://clinicaltrials.gov | Mandatory US registration. Advanced search supports NCT filter |
| PubMed | https://pubmed.ncbi.nlm.nih.gov | MEDLINE + PubMed Central. Use MeSH terms for precision |
| USPTO | https://www.uspto.gov | US patent search; use PatFT/AppFT |
| Google Patents | https://patents.google.com | Easier cross-jurisdiction search |

**Tips for US searches:**
- NDA/BLA approval letters downloadable from Drugs@FDA
- Orange Book: check both patent expiry AND exclusivity dates (can differ by years)
- EDGAR full-text search: https://efts.sec.gov/LATEST/search-index?q="drug name"

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## 🇪🇺 Europe

| Source | URL | Notes |
|--------|-----|-------|
| EMA EPAR | https://www.ema.europa.eu/en/medicines/download-medicine-data | European Public Assessment Reports with full review history |
| EMA Product DB | https://www.ema.europa.eu/en/medicines | Status: authorised / refused / withdrawn |
| CTIS | https://euclinicaltrials.eu | New EU Clinical Trials Information System (replacing EudraCT 2025) |
| EudraCT (legacy) | https://eudract.ema.europa.eu | Still accessible for historical trials pre-CTIS |
| MHRA (UK) | https://products.mhra.gov.uk | UK-specific approvals post-Brexit |
| ISRCTN | https://www.isrctn.com | UK/global registry, WHO-recognized |
| BfArM (Germany) | https://www.bfarm.de | National agency; also handles parallel import |
| ANSM (France) | https://ansm.sante.fr | French national agency |
| Swissmedic | https://www.swissmedic.ch | Switzerland — not EMA member |
| EPO / Espacenet | https://worldwide.espacenet.com | European patent search, 100+ countries |
| Embase | https://www.embase.com | Subscription. Superior drug adverse event indexing vs PubMed |

**Tips for EU searches:**
- EPAR includes refused applications and withdrawn products — check those too
- CTIS/EudraCT numbers: 2021-NNNNNN-NN format
- Post-Brexit: MHRA approvals are separate from EMA; UK often approves independently now

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## 🇯🇵 Japan

| Source | URL | Notes |
|--------|-----|-------|
| PMDA Approval DB | https://www.pmda.go.jp/PmdaSearch/iyakuSearch/ | Japanese drug approval search |
| PMDA Review Reports | https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0028.html | Public assessment reports (some English) |
| jRCT | https://jrct.niph.go.jp | Japan Registry of Clinical Trials (mandatory since 2018) |
| UMIN-CTR | https://www.umin.ac.jp/ctr/ | University Medical Information Network — legacy, still active |
| J-STAGE | https://www.jstage.jst.go.jp | Japanese scientific literature, open access |
| J-PlatPat | https://j-platpat.inpit.go.jp | Japanese patent full-text search |
| MHLW | https://www.mhlw.go.jp | Ministry of Health guidelines and policy |

**Tips for Japan searches:**
- PMDA uses Japanese drug names (カタカナ for foreign drugs); search both
- jRCT IDs: jRCT + number (e.g., jRCT2031190001)
- PMDA review reports increasingly available in English for key products
- Japan approval (承認) ≠ listed on NHI price list (収載) — check both for market access

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## 🇰🇷 South Korea

| Source | URL | Notes |
|--------|-----|-------|
| MFDS | https://www.mfds.go.kr | Ministry of Food and Drug Safety |
| MFDS PharmNet | https://nedrug.mfds.go.kr | Drug product approval database (Korean) |
| DUR system | https://www.health.kr | Drug utilization review, interaction database |
| CRIS | https://cris.nih.go.kr | Clinical Research Information Service (WHO-recognized) |
| RISS | https://www.riss.kr | Korean academic literature |
| KIPO | https://www.kipo.go.kr | Korean Intellectual Property Office (patents) |

**Tips for Korea searches:**
- MFDS uses Korean drug names; use English INN + "허가" (approval) for searches
- CRIS IDs: KCT + number
- Korea has a fast-track designation (신속심사) similar to FDA Breakthrough Therapy

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## 🇦🇺 Australia / 🇳🇿 New Zealand

| Source | URL | Notes |
|--------|-----|-------|
| TGA | https://www.tga.gov.au | Therapeutic Goods Administration |
| ARTG | https://www.tga.gov.au/resources/artg | Australian Register of Therapeutic Goods (public search) |
| TGA Public Summary | https://www.tga.gov.au/resources/auspar | Australian Public Assessment Reports (AusPAR) |
| ANZCTR | https://www.anzctr.org.au | Australia New Zealand Clinical Trials Registry (WHO-recognized) |
| Medsafe (NZ) | https://www.medsafe.govt.nz | New Zealand regulatory database |
| IP Australia | https://www.ipaustralia.gov.au | Australian patent database |

**Tips for AU/NZ searches:**
- TGA uses ARTG number as unique identifier
- ARTG categories: Prescription (Rx), OTC, Biologicals
- AusPAR = AU equivalent of EPAR; very detailed, publicly available
- ANZCTR IDs: ACTRN + 14 digits

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## 🌐 Cross-Regional & Global

| Source | URL | Notes |
|--------|-----|-------|
| WHO ICTRP | https://trialsearch.who.int | Aggregates all WHO primary registries worldwide |
| WHO Prequalification | https://extranet.who.int/pqweb | Developing market approval decisions |
| ICH | https://www.ich.org | Harmonized guidelines (E6, E9, M4, etc.) |
| Cochrane Library | https://www.cochranelibrary.com | Systematic reviews and meta-analyses |
| Lens.org | https://www.lens.org | Open patent + literature cross-search |
| Cortellis / Pharmaprojects | (subscription) | Commercial pipeline database — most comprehensive |
| GlobalData | (subscription) | Commercial competitive intelligence |
| Citeline (Citeline/Informa) | (subscription) | Trial and pipeline data |
| AdisInsight | https://adisinsight.springer.com | Partially open; drug pipeline, clinical trial summaries |
| OpenFDA | https://open.fda.gov | Machine-readable FDA data via API |
| ClinicalTrials.gov API | https://clinicaltrials.gov/api/v2 | Structured query access to CT.gov |

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## Drug Naming Cross-Reference Strategy

When searching across regions, always check:
1. **INN** (International Nonproprietary Name) — primary search key
2. **Brand names** — vary by market (e.g., same molecule, different brands in CN vs US)
3. **CAS Registry Number** — chemical identity, useful for patents
4. **WHO ATC code** — anatomical-therapeutic-chemical classification
5. **Chinese transliteration** — e.g., nivolumab → 纳武利尤单抗

Key INN resource: WHO INN list — https://www.who.int/teams/health-product-and-policy-standards/inn