General information only. Life sciences regulation in China spans NMPA product rules, PIPL/data security, human genetic resources, anti-corruption, volume-based procurement, IP, and clinical trial regimes. Facts, licences, and enforcement practice change. This is not legal advice and does not create an attorney–client relationship. Instruct qualified PRC counsel (and foreign counsel where FDA/EMA/CFIUS paths apply) before you recall product, transfer samples, answer a raid, or file a patent challenge.
Life sciences & healthcare legal cluster: Hub · Dawn raid · VBP · Hospital AR · Exclusive agency · HGR · Trial injury · CRO/CDMO · Device liability · Labeling · SaMD · Patent linkage · License · FDA WL · MDR/IVDR · Internet hospital · Trade secrets · Pharma ads · Device distribution · Sources · Checklist
How to use this page Pair each source with the cluster guide that operationalises it. This is a bibliography spine, not a substitute for full regulatory research or local counsel opinions.
Product registration, advertising & vigilance
- NMPA (National Medical Products Administration) — drug and medical device registration, MAH duties, adverse event / vigilance frameworks, recall practice notes.
- Advertising Law and medical/pharma advertising rules — claims, media, audience restrictions; link operationally to device ads and pharma promotion.
- Product Quality Law and Civil Code tort / product liability chapters — defect, failure-to-warn, and compensation theories (see implant/device liability).
- Device and drug recall management measures — administrative recall, public notice, and manufacturer obligations (see general recall guide).
Clinical research & human genetic resources
- Drug and device clinical trial management rules; GCP-oriented obligations for sponsors, sites, and investigators.
- Human Genetic Resources (HGR) regulations and biosecurity-related rules — collection, storage, utilisation, and outbound provision of China human genetic resources and related information (see HGR guide).
- Subject protection, informed consent, and ethics committee practice — operational guide: trial injury & insurance.
- Data integrity / fraud red lines — trial data compliance.
Data, privacy & digital health
- PIPL, Data Security Law, Cybersecurity Law — sensitive personal information (health), cross-border transfer paths (security assessment, standard contract, certification).
- Cluster companions: PIPL guide, transfer roadmap, clinical data orientation, SaMD & AI.
Anti-corruption, commercial & procurement
- Anti-Unfair Competition Law commercial bribery provisions; Criminal Law bribery offences; sector campaign practice (see dawn raid guide and GSK-era anti-bribery orientation).
- Volume-based procurement (VBP / 集采) policy documents and tender rules — commercial fallout in VBP distributor disputes.
- Two-invoice and distribution restructuring practice — treat as commercial + compliance, not “just sales ops.”
IP, patent linkage & deals
- Patent Law amendments implementing drug patent linkage / early resolution mechanisms; NMPA-CNIPA linkage practice (see patent linkage guide).
- Trade secret and unfair competition rules — R&D pipeline protection; general spine: trade-secret guides on this site.
- Cross-border licensing and tax/SAFE overlays — License-in/out milestones.
Outbound / foreign regulators (orientation)
- US FDA pathways when China-origin clinical or quality data supports filings; EU MDR/IVDR for devices placed on the EU market.
- CFIUS / foreign investment review for healthcare assets with sensitive data or dual-use adjacency — CFIUS guide.
Always download the current official Chinese text or authorised translation. English summaries on this portal are orientation only.
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