The National Medical Products Administration (NMPA) has issued a notification with 12 measures aimed at enhancing the administration and management of drug operations, effective immediately.
- Applicants for new pharmaceutical wholesale enterprises must have a self-operated warehouse that complies with requirements and is managed by the enterprise’s personnel.
- New drug retail enterprise applicants (excluding those selling only Class B over-the-counter drugs) must employ licensed pharmacists and technicians. Those handling blood products and cell therapy biological products must ensure quality assurance and traceability. Enterprises dealing in cell therapy biological products should also facilitate electronic prescription information sharing with designated medical institutions.
- Guide wholesale enterprises to achieve modern logistics through facility and equipment upgrades and resource integration.
- Wholesale enterprises with a specific drug business scope must clearly indicate this in their business scope, such as “Chinese medicine decoction pieces (including poppy shells)”, “chemical drugs (including refrigerated and frozen drugs)”, and “retail (chain headquarters)”.
- Strengthen management of drug business licenses by medical products administration bureaus, preventing cancellation in cases of pending filings or incomplete administrative penalties.
- Drug retail chain enterprises must purchase drugs through their headquarters for distribution to chain stores.
- Drug retail enterprises may operate self-service vending machines for Class B OTC drugs, adhering to storage requirements, and are prohibited from selling Class A OTC drugs or prescription drugs.
- MAHs or drug trading enterprises must sign a quality agreement with any party entrusted for storage and transportation.
- The process for pharmaceutical wholesale enterprises establishing new warehouses in other provinces will be based on warehouse address changes.
- Encourage electronic exchange and management of initial information by pharmaceutical trading enterprises.
- Accelerate full-process drug information traceability, focusing on VBP winning bids, biological products, and other varieties.
- Medical products administration bureaus must increase efficiency in drug operation administration based on the “Drug Operation and Use Quality Administration and Management Measures”.- Flcube.com
