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.
Regulatory Scope and Licensing Clarifications
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.
Strengthened Quality Management and Supervision
The “Measures” reinforce the quality management responsibilities of drug Marketing Authorization Holders (MAHs) and drug operation enterprises. They refine management requirements for personnel involved in drug purchasing and selling, as well as for storage and transportation activities. The document emphasizes the quality management requirements for entrusted storage and transportation activities of drug MAHs and operation enterprises, and proposes requirements for the unified management of retail chains by their headquarters.
Inspection and Oversight Provisions
In terms of supervision, the “Measures” mandate that inspections of enterprises dealing in narcotic drugs, first-class psychotropic drugs, and pharmaceutical precursor chemicals must occur at least once every six months. Additionally, inspections of enterprises handling refrigerated and frozen drugs, blood products, cell therapy biological products, second-class psychotropic drugs, and medical toxic drugs must be conducted at least once a year.
Comprehensive Process Supervision
The “Measures” also emphasize the supervision of the entire process of drug operation and use, making provisions for the quality management department and personnel, storage and maintenance, handling of drug quality issues and recalls, and drug traceability in medical institutions. The division of responsibilities among drug regulatory departments at all levels and cross-regional regulatory responsibilities are further clarified to ensure comprehensive oversight.-Fineline Info & Tech
