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
What counts as advertising / promotion
Beyond TV and print: WeChat, KOL livestreams, patient education that names products, conference booths, MSR/MR detailing aids, and “medical science” decks that effectively sell. If it influences prescribing or purchase, run medical-legal review—do not hide behind “internal training” labels when materials leave the company.
Claim and audience controls
- Align all claims to the approved China label / instructions—no global brochure copy-paste.
- Disease-awareness campaigns need bright lines so they do not become product ads for prescription drugs.
- Comparative claims and “first / only / best” language need evidence and often heightened risk.
- Patient-facing vs HCP-facing versions must not contradict each other.
Off-label promotion risk
HCPs may use products off-label; manufacturers create exposure when promotion, MSL scripts, or patient materials push unapproved indications or doses. Train for reactive scientific exchange protocols; document unsolicited requests. Liability and labeling interface: labeling & ADR guide.
Medical representatives & HCP engagement
MR activity sits at the junction of advertising rules and anti-bribery controls. Speaker fees, advisory boards, and hospitality need FMV and substance files — dawn raid playbook. Detailing aids should be version-controlled like regulated labels.
Internet, e-commerce & internet hospitals
Online channels amplify false-advertising and prescription-drug promotion risks. Platform pharmacies and internet hospitals have their own licensing overlay — internet hospital guide. Influencer contracts must include take-down and script-approval rights.
Medical-legal review operating model
- Single intake queue for all external-facing content.
- Reviewers: medical + legal + compliance (and regulatory when claims change).
- Retention of approved versions and rejection logs for inspections.
- Agency clauses: no publication without approval; audit rights; indemnity for rogue posts.
Enforcement & remedies posture
Expect advertising orders, fines, corrective statements, and traffic-platform takedowns. Parallel civil unfair-competition claims from competitors appear when comparative ads overreach. Coordinate response with PV if safety claims are implicated.
90-day uplift plan
- Inventory all live WeChat/web assets against current China label.
- Kill orphan PDFs on sales laptops.
- Rebuild speaker-fee SOP with FMV grid.
- Tabletop a false-ad complaint with comms + legal.
