CCTV News: According to the website of the National Medical Products Administration, the spokesperson of the National Medical Products Administration answered questions from reporters on the white paper "China's Fentanyl Substance Control".
Q: Recently, the State Council Information Office released the white paper "China's Fentanyl Substance Control". What is the management of China's fentanyl drugs production, operation and export? Is there a problem of losing fentanyl drugs from legal companies?
A: Fentanyl drugs are mainly used for clinical analgesia. The use of non-medical purposes will cause drug abuse and even lead to public health and social problems. Up to now, there are 4 fentanyl drugs in my country approved for marketing as drugs, namely fentanyl, sufentanyl, remifentanyl and afentanyl. Three companies were allowed to produce raw materials, and five companies were allowed to produce preparations.
In 2024, the production volume of fentanyl-based drug raw materials in my country was 100 kilograms, mainly used for domestic medical use and export. In 2024, my country's export of fentanyl drugs was 12.3 kilograms (based on the bases of fentanyl substances), mainly exported to countries such as South Korea, Vietnam, and the Philippines. Up to now, my country has never exported fentanyl drugs to North America.
In my country, all fentanyl drugs are included in the management of narcotic drugs. The drug regulatory authorities implement the strictest controls on fentanyl drugs, implement production and operation by enterprises, production and operation through fixed channels, and sales through exports through license management. Regular inspections are carried out on the production and operation of fentanyl drugs to promptly check for safety risks and hidden dangers. Organize special inspections and flight inspections to effectively standardize production and operation order. An international verification system is implemented for the export of fentanyl drugs, and an export permit is issued after the importing country's competent authorities confirm the legality of trade. A warning and education meeting for the production, operation and export of fentanyl drugs was held to enhance the awareness of law-abiding operations in enterprises and build a solid line of defense for fentanyl drugs. Through the joint efforts of regulatory authorities and enterprises, the production, operation and management of fentanyl drugs has been stable. No cases of illegal production and operation of fentanyl drugs in drug production and operation enterprises, nor have they been found that fentanyl drugs flowed into illegal channels from drug production and operation enterprises.
In the next step, the State Food and Drug Administration will continue to strengthen the supervision and management of fentanyl drugs production and operation, strictly approve the export of fentanyl drugs, ensure the medical needs of fentanyl drugs, and strictly prevent the inflow of illegal channels and abuse.

