China’s National Medical Products Administration (NMPA) released the “Announcement on the Provisions for the Administration of Record-Filing of Internet Pharmaceutical and Medical Device Information Services,” effective immediately. The regulation mandates that all websites, mobile clients, and applications providing pharmaceutical or medical device information services in China must prominently display their record-filing certificate numbers and prohibits publishing information on narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, drug rehabilitation medications, and hospital-made preparations.
Regulatory Milestone
Item
Details
Issuance Date
22 Dec 2025
Effective Date
Date of publication (immediate)
Agency
National Medical Products Administration (NMPA)
Document
Provisions for Administration of Record-Filing of Internet Pharmaceutical and Medical Device Information Services
Scope
All internet platforms providing pharma/medical device info services within China
Enforcement Body
NMPA responsible for nationwide guidance and supervision
Key Provisions
Requirement
Details
Record-Filing Display
Websites/clients/apps must continuously and prominently display certificate number on homepage/main interface
Prohibited Content
Narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, drug rehabilitation medications, hospital-made preparations (strictly banned)
Compliance Timeline
Immediate enforcement; platforms must update within 30 days
Penalty Structure
Non-compliance may result in service suspension, fines up to ¥500,000, or criminal referral
Market Impact
Stakeholder
Impact
Internet Platforms
~2,000+ health info sites require immediate compliance updates; estimated ¥50‑80 million in aggregate compliance costs
Digital Health Startups
Increased regulatory barrier to entry; existing platforms with robust compliance gain competitive advantage
Pharma Advertisers
Restricted from promoting controlled substances online; forces shift to approved drug information only
Consumers
Enhanced safety and information accuracy; reduced exposure to illicit drug promotions
Strategic Implications
For Platforms:Compliance overhaul required within 30 days; major players (Alibaba Health, JD Health) likely already compliant; smaller apps face significant upgrade costs or risk shutdown.
For Pharma:Digital marketing strategies must exclude prohibited categories; record-filing transparency increases accountability; may accelerate partnerships with compliant platforms.
For Market:Regulatory tightening favors consolidation among large, well‑funded digital health players; NMPA’s digital oversight signals future telemedicine and e‑prescription regulations are imminent.
Forward‑Looking Statements This brief contains forward‑looking statements regarding enforcement intensity, compliance costs, and platform adaptation timelines. Actual results may differ due to local implementation variations, judicial interpretations, or policy amendments.-Fineline Info & Tech
By Fineline Cube 