China’s State Administration for Market Regulation (SAMR) has released the “Measures for the Supervision and Administration of Online Drug Sales,” effective December 1, 2022. The 42-article regulation aims to ensure drug quality, safety, and accessibility, targeting online retailers, platforms, and prescription drug sales.
Drug Operator Responsibilities
The rules clarify qualifications for online sellers, banning sales of vaccines, blood products, narcotics, psychotropic drugs, and other restricted medications. Retailers must authenticate prescriptions, avoid gifting prescription drugs, and maintain records for at least five years post-expiration.
Platform Oversight
Third-party platforms must establish quality management systems, staff pharmacists, and enforce rules on drug display, prescription review, and real-name purchases. Platforms are required to audit sellers, suspend violators, and retain transaction records for five years.
Prescription Drug Sales
Online prescription drugs must follow a real-name system and separate display from non-prescription items. Packaging, labels, and instructions cannot be shown before prescription review. Consumers must acknowledge risk warnings before purchasing.
Regulatory Enforcement
SAMR outlined local authorities’ roles in monitoring online sales and penalizing violations. The rules emphasize risk control and legal accountability for illegal drug sales.-Fineline Info & Tech
