II. Ensuring Both Rational Use and Rigorous Control

Currently, China has approved fentanyl, sufentanil, remifentanil, and alfentanil for pharmaceutical use in the forms of transdermal patches and injections only. In the 1970s, China began to approve the production of fentanyl-related substances for medical purposes, and fentanyl injections were approved in 1974. Subsequently, remifentanil injections were approved in 2003, sufentanil injections and fentanyl transdermal patches in 2005, and alfentanil injections in 2020. Compared with traditional opioids such as morphine and pethidine, these fentanyl-related medications are rapid in onset, strong in effect, and long in duration. They have few side effects and enable quick recovery from anesthesia. With these advantages, they are widely used in the induction and maintenance of intraoperative anesthesia, postoperative and labor analgesia, and for the relief of cancer pain, thereby ensuring that the public have ready access to effective medications. Fentanyl-related medications now account for around 66 percent of the market share of narcotic drugs and Class I psychotropic substances in China.

China has enumerated fentanyl-related medications in the List of Controlled Narcotic Drugs and exercises strict control in terms of their manufacturing, sale, use, and export.

– The manufacturing of fentanyl-related medications is limited to certain enterprises and subject to annual planning. Currently, China has approved five companies for manufacturing fentanyl-related medications – Yichang Humanwell Pharmaceutical Co., Ltd., the Langfang Branch of China National Pharmaceutical Industry Corporation Ltd., Jiangsu Nhwa Pharmaceutical Co., Ltd., Henan Lingrui Pharmaceutical Co., Ltd., and Changzhou Siyao Pharmaceuticals Co., Ltd. They must conform to Good Manufacturing Practice (GMP) of Medical Products with security facilities combining manpower, equipment, and technology. They must strictly carry out the annual plans for production defined by the National Medical Products Administration (NMPA), and report regularly on the production, sales, and inventory of fentanyl-related medications to drug supervision authorities. In 2023, Chinese enterprises manufactured a total of 84.969 kilograms of fentanyl-related bulk drug substance (BDS), including 9.89 kilograms of fentanyl BDS, 4.702 kilograms of sufentanil BDS, 5.805 kilograms of alfentanil BDS, and 64.572 kilograms of remifentanil BDS. In 2006, China approved Xi'an Janssen Pharmaceutical Ltd. as an importer of fentanyl-related medications, limited to fentanyl transdermal patches only.

– The sale of fentanyl-related medications is limited to certain enterprises and approved channels. Currently, three national wholesalers – China National Medicines Corporation Ltd., Shanghai Pharmaceutical Co., Ltd., and Chongqing Pharmaceutical (Group) Co., Ltd. – as well as 626 regional wholesalers (in 2023) are accredited to engage in the sale of fentanyl-related medications in China. Manufacturers must sell fentanyl-related medications to the three national wholesalers who resell them to provincial-level regional wholesalers before the medications enter the medical institutions in the said provinces and equivalent administrative units. Pharmaceutical retail companies are not allowed to sell fentanyl-related medications. In 2023, China had domestic sales of 20.86 kilograms of fentanyl BDS, 5.21 kilograms of sufentanil BDS, 6.84 kilograms of alfentanil BDS, and 63.06 kilograms of remifentanil BDS, including carryovers from 2022. To date, no cases of fentanyl-related medications disappearing in manufacturing or circulation have been detected in China.

– The use of fentanyl-related medications is subject to strict management by medical institutions. China places the use of fentanyl-related medications under the strictest control. They are subject to medical prescription and real-name patient registration, and are securely stored in cabinets with double locks handled by authorized medical workers each with a key. Newly-prescribed medications can only be obtained by presenting the used packages of previous prescriptions. In addition to these security measures, law enforcement and administrative departments have strengthened communication for the timely identification of problems and weak points and the closure of administrative loopholes. Since 2017, three criminal cases of trafficking fentanyl-related medications have been concluded in China, and no cases of outbound smuggling and trafficking of fentanyl-related medications have been detected.

– The export of fentanyl-related medications is subject to permit administration. The NMPA implements a permit system for the export of fentanyl-related medications. Based on strict examination and approval, the NMPA verifies with and obtains confirmation of legality of the transaction from the competent authorities of the importing country for each exported shipment of narcotic drugs before issuing a permit for export. Currently, Yichang Humanwell Pharmaceutical Co., Ltd. is China's only exporter of fentanyl-related medications. In 2023, China exported 9.766 kilograms of fentanyl-related medications, mainly to Asian countries including the Republic of Korea, Vietnam, Malaysia, and the Philippines, Latin American countries including Chile, Panama, Columbia, and Paraguay, and European countries including Poland, Germany, and France. China has never exported any type of fentanyl-related medication in any form to North America.

China has worked actively to establish a digital tracking system for fentanyl-related medications. The comprehensive use of new technologies and methods, such as radio frequency identification tags, the Internet of Things, and artificial intelligence, enables whole-process dynamic monitoring and closed-loop management of the manufacturing, sale, transport, use, import, and export of fentanyl-related medications, which further prevents them from becoming lost.