The State Administration for Market Regulation (SAMR) has released the “Drug Operation and Use Quality Administration and Management Measures,” set to take effect from January 1, 2024. These measures will apply to the quality management and supervision of drug operation, use, and management activities within China, ensuring stringent standards for pharmaceuticals, including vaccines and other controlled substances.<\/p>\n\n\n\n
Regulatory Scope and Licensing Clarifications<\/strong>
The “Measures” provide clear licensing conditions and application material requirements for pharmaceutical wholesale enterprises, retail chain headquarters, and retail enterprises. They aim to simplify the approval process for pharmaceutical business licenses, optimize the establishment standards for pharmaceutical wholesale enterprises, and clarify the standards for verifying the business scope of these entities. For applicants engaging solely in Class B over-the-counter drug retail activities, a drug trading license will be issued on the same day if their application materials and commitment letter meet the conditions.<\/p>\n\n\n\n