The Ministry of Industry and Information Technology (MIIT), National Health Commission (NHC), National Healthcare Security Administration (NHSA), and National Medical Products Administration (NMPA) have jointly released a notification to enhance the monitoring of drugs in clinical shortage. The notice includes a list of 109 drug varieties, with volume – based procurement (VBP) winning drugs also subject to monitoring, alongside their manufacturers and distribution channels. The list of monitored drug varieties and enterprises will be dynamically adjusted, and distribution evaluations will be carried out in a timely manner.
Monitoring Responsibilities
Manufacturers of in – shortage drugs and VBP winners are responsible for reporting production reserve monitoring information. Local industry and information technology bureaus, together with relevant departments, are tasked with monitoring the production reserves of in – shortage and VBP drugs in their regions. They are also required to organize enterprises to submit relevant data, review the completeness and accuracy of the data, strengthen supervision and inspection of drug quality, and urge manufacturers to implement their responsibilities for sufficient supply and production suspension reporting in accordance with the purchase agreement.
Details of Monitored Drugs and Enterprises
The 109 in – shortage drugs involve over 460 manufacturers, including multinational companies such as Merck, Ferring, Sanofi, and Pfizer. Before the 10th of each month, manufacturers of in – shortage and VBP drugs should fill in monitoring reports through the “Monitoring and Early Warning Platform for Production and Supply of Drugs in Shortage” (website: www.dqyjc.org.cn). The 10 key companies responsible for maintaining drug reserves are: China National Pharmaceutical Group Corporation, China Meheco Group Co., Ltd, Tianjin Pharmaceuticals, Chongqing Medicines (Group) Co., Ltd, Xinjiang Production and Construction Corps Pharmaceutical Co., Ltd, China Resource Medicine Commercial Holdings Ltd, Jointown Pharmaceutical Group Co., Ltd, AliHealth Pharmacy Pharmaceutical Chain Co., Ltd, JD Health, and Dingdang Kuaiyao Technology Group Co., Ltd.-Fineline Info & Tech
