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In response to a media inquiry regarding the production, operation, and export management of fentanyl-related substances in China, as well as whether there is any issue of fentanyl-related substances leaking from legitimate enterprises, a spokesperson for the National Medical Products Administration (NMPA) said China has never exported fentanyl-related pharmaceuticals to North America. 
 
China's State Council Information Office released a white paper on March 4, 2025 titled “Controlling Fentanyl-Related Substances - China's Contribution,” highlighting the country's rigorous control over these chemicals.

The spokesperson noted that in 2024, China produced 100 kilograms of fentanyl-based active pharmaceutical ingredients, primarily for domestic medical use and export. That year, China exported 12.3 kilograms of fentanyl-related medications, measured as fentanyl-related substances, mainly to South Korea, Vietnam, and the Philippines.

Fentanyl-related medications are primarily used for pain relief in clinical settings. Non-medical use can lead to drug abuse and even cause public health and social issues. As of now, a total of four fentanyl-related medications have been approved for marketing in China: fentanyl and its derivatives sufentanil, alfentanil and remifentanil. Three companies have been authorized to produce active pharmaceutical ingredients, while five companies have been approved to manufacture formulations, the spokesperson said.

The spokesperson emphasized that China has enumerated fentanyl-related medications in the List of Controlled Narcotic Drugs. The drug regulatory authorities implement the strictest control measures for fentanyl-related medications. Production and business operations are carried out through designated enterprises, with production based on demand and fixed sales channels, while exports are subject to licensing management. Regular inspections and checks are conducted on the production and operation of fentanyl-related medications to promptly identify potential safety risks. Special inspections and surprise checks are organized to effectively regulate the production and business order.

The spokesperson further noted that the export of fentanyl-related medications is subject to an international verification system. An export permit is issued only after the legality of the trade is confirmed by the competent authorities of the importing country. Warning and educational meetings are held for the production, operation, and export enterprises of fentanyl-related medications to enhance their awareness of legal compliance and strengthen the safety defense line for fentanyl-related medications.

Through the joint efforts of regulatory authorities and enterprises, the production and operation management of fentanyl-related medications have remained stable. No illegal production or operation of fentanyl-related medications has been found in pharmaceutical enterprises, nor have fentanyl-related medications been discovered to flow into illegal channels from pharmaceutical production and business enterprises, said the spokesperson.

Moving forward, the NMPA will continue to enhance the supervision and regulation of the production and distribution of fentanyl-related medications. It will enforce strict approval processes for exports, ensure a stable medical supply, and implement robust measures to prevent diversion into illegal channels and misuse, the spokesperson added.

Global Times