Measures for the Supervision and Administration of Drug Quality in Operation and Usage Released
ISSUING AUTHORITY:
State Administration for Market Regulation
DATE OF ISSUANCE:
September 27, 2023
EFFECTIVE DATE:
January 1, 2024
On September 27, 2023, the State Administration for Market Regulation released the Measures for the Supervision and Administration of Drug Quality in Operation and Usage (“Measures”), with an effective date of January 1, 2024.
Firstly, the Measures improve the management of the drug operating permit. The Measures provide clarity on the licensing conditions and required application materials for drug wholesalers, drug retail chain headquarters, and drug retailers, and streamline the approval process for obtaining a drug operating permit. Where an applicant only engages in the retail activities of Class B OTC drugs, provided that the requirements are met, the drug operating permit shall be issued on the same day that the applicant submits the application materials.
Secondly, the Measures strengthen the quality management responsibilities assigned to the drug marketing authorization holder and drug operators, refine their management requirements for drug purchase and sales personnel, purchase and sales behaviours, storage, and transportation, etc., emphasize the quality management requirements for storage and transportation activities entrusted by the drug marketing authorization holder and drug operators. But it also introduces the requirement that whoever engages in drug retail chain business activities shall establish a drug retail chain headquarters to conduct unified management of the retail stores.
In addition, stricter regulations regarding quality management in medication usage have been introduced. Provisions are made for the quality management departments and personnel of drugs in medical institutions, storage and maintenance, handling of drug quality problems, drug recall, and the traceability of drugs. Medical institutions and other entities using drugs are required to establish a drug quality management system and are responsible for the quality management in the whole process of the purchase, storage and use of drugs.
In conclusion, the Measures provide a more specific and comprehensive framework for the allocation of regulatory responsibilities among drug regulatory departments at the national, provincial, city, and county levels. It also enhances administrative measures to ensure the full and effective implementation of such responsibilities.
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