The National Medical Products Administration (NMPA) has released a notification aimed at enhancing the quality oversight and supply security of drugs related to COVID-19 prevention and control. The guidelines focus on ensuring the quality and legal supply of common drugs listed in the “Guidelines for Home Treatment of COVID-19 Infected Persons.”
Quality Management and Regulatory Requirements
The document emphasizes the implementation of primary responsibilities by enterprises and the strengthening of quality management. Local drug regulatory departments are required to urge and guide drug retailers within their jurisdictions to strictly comply with relevant laws and regulations. This includes checking purchase and marketing channels, storage and maintenance, pharmaceutical services, and distribution traceability. Retailers must ensure that the source of drugs is legal, sales are compliant, drug guidance is in place, and the whereabouts of drugs can be traced. The business process must continue to meet legal requirements, and measures must be taken to prevent counterfeiting and the sale of expired or invalid drugs.
Supervision and Guidance
The document also calls for strengthened supervision and guidance, specifying requirements for the sale of disassembled parts. Localities are required to supervise and guide drug retail enterprises in unbundling sales, urging them to establish and improve quality management systems and sales procedures for drug unbundling. Retailers must equip themselves with the necessary facilities and tools and arrange specially trained personnel to carry out the unbundling work. Unpacked drugs should be stored in a designated area, and sub-packaging labels must indicate essential information such as the drug name, manufacturer, specification, quantity, usage, dosage, batch number, expiry date, and pharmacy name. Retailers must keep records of the sale of broken-down parts and provide drug instructions and usage guidance to consumers.
Publicity and Education
In addition to regulatory measures, the document encourages active publicity and education to guide rational drug purchases. Local drug regulatory authorities are urged to closely monitor the latest requirements for COVID-19 prevention and control, conduct policy publicity and interpretation, ensure the supply of commonly used drugs, and carry out drug safety publicity and consumption warnings. Authorities are also tasked with monitoring public opinion and guiding consumers to purchase drugs rationally.
Future Outlook
The NMPA’s latest notification underscores the importance of maintaining high standards in drug quality and supply security during the COVID-19 pandemic. By strengthening oversight and providing clear guidelines for drug retailers, the administration aims to ensure that patients have access to safe and effective medications. The emphasis on publicity and education also highlights the need to inform consumers about rational drug use and safety.-Fineline Info & Tech
