China's White Paper on Controlling Fentanyl
China’s State Council Information Office (SCIO) today published a white paper titled "Controlling Fentanyl-Related Substances - China's Contribution."
Given the issue's importance, and the fact that it’s challenging to locate the full text in English (you can’t find it in the SCIO or foreign ministry website, for example), here it is.
Some exercepts from the white paper
I. Defining Fentanyl-Related Substances Based on Science
On April 1, 2019, China issued a statement to implement full control of fentanyl-related substances…China introduced the concept of “related substances” and provided an accurate and scientific legal definition of fentanyl-related substances. This definition covers all types that require scheduling in the list of controlled substances, provides a strong legal basis for striking against drug crimes involving fentanyl-related substances, and minimizes the impact on legitimate needs in fields such as medicine, industry, and scientific research.
Fentanyl-related substances are obtained through chemosynthesis, and the chemical raw materials used to manufacture fentanyl-related substances are collectively known as their precursors. The synthetic routes to chemicals are diverse and the many alternatives make easy substitutions. In recent years, the precursors of fentanyl-related substances have constantly changed, and the number of variations soared. 4-anilino-N-phenethylpiperidine (4-ANPP) and N-phenethyl-4-piperidone (NPP) are two most immediate precursors of fentanyl-related substances. They were listed as controlled substances in Table I annexed to the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (the “1988 Convention”) at the 60th session of the UN’s Commission on Narcotic Drugs in March 2017, and included in the Catalog of Classification and Types of Scheduled Precursor Chemicals annexed to the Regulations on the Administration of Scheduled Precursor Chemicals by China in the same year.
II. Ensuring Both Rational Use and Rigorous Control
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.
III. Striking Hard Against Fentanyl-Related
Crimes in Accordance with the Law
China actively responds to new challenges associated with fentanyl-related substances. To prevent the abuse of fentanyl-related substances and to combat and control related crimes to the greatest extent possible, it has adopted integrated measures such as expanding the list of controlled substances, strengthening regular supervision, stepping up inspection and seizure, and implementing innovative controls.
– Expanding the list of controlled substances in a timely manner. China actively fulfills its obligations as a contracting state to UN’s Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971. In accordance with relevant provisions of its Regulations on Administration of Narcotic Drugs and Psychotropic Substances and Measures on the Control of Nonmedical Narcotic Drugs and Psychotropic Substances, China expands its list of controlled substances in line with the United Nations control list in a timely manner.
Its List of Controlled Narcotic Drugs (2013) enumerates 13 types of fentanyl-related substances. Its Supplementary List of Nonmedical Narcotic Drugs and Psychotropic Substances was expanded to include the following:
• Acetylfentanyl and five other types of fentanyl-related substances in October 2015;
• Carfentanil, furanylfentanyl, acrylfentanyl and valerylfentanyl in March 2017;
• Tetrahydrofuranylfentanyl and 4-fluoroisobutyrfentanyl in September 2018.
Before bringing all types of fentanyl-related substances under control, China had already listed 25 types of controlled fentanyl-related substances, more than the number on the United Nations control list in the same period.
– Implementing full control of fentanyl-related substances. China proactively engages in drug control. To safeguard the health, safety, and wellbeing of all of humanity, China has actively responded to the concerns of the international community in dealing with fentanyl-related substances. In China, the harm these substances have caused is limited. Still, China takes precautions and preemptive actions to prevent and address the potential risks and hazards posed by such new drugs.
On April 1, 2019, China issued a statement announcing full control of fentanyl-related substances to be effective from May 1, 2019, making it the first country in the world to impose full control of fentanyl-related substances. China’s policy is sounder, stricter, and broader in scope than mechanisms such as scheduling of fentanyl analogues, genetic control, and temporary scheduling in other countries. In addition, by formulating and implementing the Action Plan for Implementing Full Control of Fentanyl-related Substances, strengthening top-level design and overall planning, and employing integrated measures such as monitoring and early warning, regular supervision, law enforcement to combat crimes, and public communication and education, control over these substances has been effectively strengthened.
– Improving the legal framework. After extensive research, scientific experiments, and expert verification, the Supreme People’s Court, the Supreme People’s Procuratorate, and the Ministry of Public Security formulated guidelines on issues concerning the application of law in handling criminal cases involving fentanyl-related substances. The Supreme People’s Procuratorate and the Ministry of Public Security formulated regulations on the thresholds for filing and proceeding with criminal cases involving fentanyl-related substances. The Ministry of Public Security formulated and released the conversion table on fentanyl-related substances. These documents set the thresholds for filing and proceeding with criminal cases involving fentanyl-related substances, and the standards for convicting and sentencing those accused, providing a basis and legal guarantee for related law enforcement and judicial work.
– Maintaining a tough stance against related crimes. Public security organs have struck hard against crimes involving fentanyl-related substances in accordance with the law. After fentanyl-related substances were put under full control in May 2019, the Ministry of Public Security launched special campaigns three years in a row to combat the illegal manufacturing and trafficking of fentanyl-related substances and other new drugs. In 2023, it launched a special campaign to wipe out fentanyl-related substances, working with the customs authorities to step up efforts to inspect exported cargo and articles at key ports, especially those to key countries. In another campaign in collaboration with the State Post Bureau to stem drug delivery through logistic services, it reiterated the supervisory duties of competent departments and the primary accountability of delivery services. A multi-agency mechanism for inspection and seizure was established, and intelligence analysis and special case investigations were strengthened. Since implementing full control of fentanyl-related substances, China has not detected any further cases of smuggling or selling fentanyl-related substances abroad.
– Tightening the regulation of online information. In response to illegal online postings of sales information concerning fentanyl-related substances and their precursors, the Office of China National Narcotics Control Commission, together with competent authorities, has urged online platforms in the chemical industry to implement measures like real-name registration for users, examination and approval of postings, online information inspection, and handling and reporting of harmful information. The release of sales information on suspicious chemicals is strictly prohibited, and any issues or leads found must be promptly reported to public security departments to be dealt with. Public security departments have tightened the regulation and cleanup of online information on fentanyl-related substances and related precursors. As of June 2024, more than 140,000 illegal advertisements had been blocked or removed and 14 online platforms were ordered to take corrective action or shut down.
IV. Enforcing Strict Control over Precursors
of Fentanyl-Related Substances
China has established complete legal and administrative systems for scheduled precursor chemicals. It has also formed a regulatory system based on the Regulations on the Administration of Scheduled Precursor Chemicals, and supported by the Measures on Licensing the Production and Sale of Scheduled Non-pharmaceutical Precursor Chemicals, Measures on the Administration of the Purchase, Sale, and Transportation of Scheduled Precursor Chemicals, Measures on the Administration of Scheduled Pharmaceutical Precursor Chemicals, Regulations on the Administration of the Import and Export of Scheduled Precursor Chemicals, and Regulations on the Administration of International Verification of the Import and Export of Scheduled Precursor Chemicals.
Authorities in charge of public security, commerce, emergency management, public health, customs, and medical products administration expand the control list of precursors of fentanyl-related substances and supervise their production, sales, purchase, transportation, and export in accordance with their respective responsibilities.
– Expanding the control list effectively and responsibly. Taking into consideration production needs and the risk of misappropriation, China places chemicals that could be used to manufacture fentanyl-related substances on the control list of scheduled precursor chemicals in a timely manner. The following five types of precursors have been brought under control: 4-ANPP, NPP, 4-AP, 1-boc-4-AP, and norfentanyl, and all precursors of fentanyl-related substances that were on the United Nations control list before 2024 have been covered. Work on scheduling 4-piperidone and 1-boc-4-piperidone, which the United Nations added to its control list in 2024, is underway.
– Adopting multi-level and category-specific supervision. In accordance with the Regulations on the Administration of Scheduled Precursor Chemicals, 4-ANPP and NPP are managed as Class I scheduled precursor chemicals. Enterprises applying for their production and sale must be approved by the emergency management departments of provincial-level governments. Applications for their purchase must be approved by the public security departments of provincial-level governments, and applications for their transportation must be approved by the public security departments of governments of cities (with districts). Substances like 4-AP, 1-boc-4-AP, and norfentanyl are managed as Class II scheduled precursor chemicals. Within 30 days from their production and sale, manufacturing enterprises must report the type and quantity of the chemicals they produce, and trading enterprises must report the type, quantity and main destinations of the chemicals they sell, among others, to the local emergency management departments of governments of cities (with districts), and their purchase and transportation must be approved by the local public security departments of county-level governments.
– Strictly supervising exports. For the five types of precursor chemicals already under control, a strict approval, permit, and international verification system is in place. Before the Ministry of Commerce examines applications for export permits, the Ministry of Public Security sends a verification request to the competent authorities of the importing country through the International Narcotics Control Board (INCB)’s Pre-Export Notification (PEN) Online system. After receiving the feedback verifying the legality of the transaction, the Ministry of Commerce issues permit in accordance with the law. The customs departments proceed with export clearance with declaration documents and the export permit. Since establishing control over the five aforementioned precursors, there has been no recorded application for export by Chinese enterprises.
– Realizing closed-loop supervision through informatization. A national management system for precursor chemicals has been established, available free of charge to enterprises, enabling the collection of all data for the management of scheduled precursor chemicals in China through one platform. The Ministry of Public Security and 10 other departments issued the Guidelines on the Establishment of a Digital Tracking System for Scheduled Precursor Chemicals to achieve dynamic and full-process monitoring of their production, sale, purchase, transportation, import, and export by building a supervision system for the identification and traceability of scheduled precursor chemicals. At the same time, emphasis has been placed on the role of industry associations and a credit rating system has been implemented to promote self-discipline among enterprises.
As the international community invests more effort in implementing the 1988 Convention, controlled chemicals have become more difficult to obtain. Lawbreakers abroad are constantly updating drug-manufacturing techniques, and more often using uncontrolled chemicals to manufacture drugs, especially by exploiting the differences in chemical control laws between countries. They purchase uncontrolled precursors of fentanyl-related substances online via virtual currency payment and international parcel delivery to evade regulatory scrutiny. This has become a prominent challenge for governing fentanyl-related substances. China pays close attention to this issue, and has adopted a series of strong measures such as monitoring and early warning, online inspection, prioritizing key areas, and circulating notifications, to prevent the flow of uncontrolled chemicals into illegal overseas channels.
VI. Adopting Comprehensive Measures for
More Efficient Drug Control
China has made full use of its political and institutional strengths, and adopted comprehensive policy, legal, administrative, economic, and social measures for the control of fentanyl-related substances. To achieve effective protection against fentanyl-related risks and hazards, it has strengthened Party and government leadership, reinforced coordination across departments, promoted industry self-regulation, and raised public awareness.
– Strengthening accountability for drug control. China has exercised drug control from an overall and strategic perspective. It has formulated a responsibility evaluation method for areas afflicted by serious drug-related crime, and clarified the responsibilities of governments at all levels for drug control. Local authorities are required to closely monitor biopharmaceutical research and development centers, chemical and pharmaceutical parks, and other critical entities at high risk of involvement in the research and development of synthetic drugs such as fentanyl-related substances. They are responsible for setting up task forces to conduct thorough examinations, identify key enterprises, individuals and facilities, document their information, and keep them under close scrutiny. Officials who allow threats to develop by failing to grasp the gravity of the situation or failing to carry out their duties in full will be subject to oral investigation, exposure of their errors, or follow-up supervision. They will be required to rectify the problems within a specified deadline. Those whose negligence results in severe consequences and adverse impacts will be held accountable in accordance with relevant regulations.
– Reinforcing coordination across departments. Cyberspace, public security, and industry and information technology authorities have worked together to strengthen internet regulation. They have urged online chemical industry platforms to strengthen real-name authentication, conducted an intensive campaign to address websites and instant messaging platforms carrying information involving drug-related crime, and closed down non-compliant services in accordance with the law. Postal authorities have reinforced supervision and guidance on delivery services, and intensified efforts to ensure full implementation of the regulations requiring inspection of packages upon acceptance and dispatch, real-name authentication for delivery requests, and security screening through machines, with targeted measures for strengthening the detection and seizure of drugs. Customs authorities have reinforced risk assessment and port supervision, and devoted targeted efforts to prevent the smuggling of fentanyl-related substances through intensified inspections of high-risk cargo and articles. Authorities responsible for public health, market regulation, medical products supervision, and other sectors have worked in coordination to address and sanction medical institutions involved in fentanyl-related abuse, and take proactive measures to prevent the abuse of fentanyl-related medicines.
– Carrying out specialized education and training. In 2019, the Office of China National Narcotics Control Commission issued the Notice on Preventing Illegal and Criminal Acts Relating to Nonmedical Narcotic Drugs and Psychotropic Substances and Precursor Materials. The notice serves as a reminder to businesses and individuals in relevant industries by reiterating laws, regulations, and sanctions concerning drug control. In 2023, the office issued a new notice urging businesses and individuals to heighten their legal awareness and guard against the use of their exported goods for producing drugs and the attendant risk of legal liabilities. The office designed and circulated posters on preventing risks associated with fentanyl-related substances and other new drugs, and organized specialized training sessions aimed at improving the identification skills of professionals in relevant fields, in order to reinforce their awareness and ability to prevent risks and detect problems.
– Raising public awareness against drug abuse. Extensive public education has been carried out nationwide to prevent the abuse of narcotic drugs, psychotropic substances, fentanyl-related substances, and other addictive substances. Through collaborative efforts across departments, intensive educational campaigns have been conducted to raise awareness about the dangers of illicit drug use. Targeted at teenagers, comprehensive, well-conceived, and systematic activities have popularized understanding of issues related to addictive substances, including fentanyl-related substances, clarified the dangers of abuse, and consolidated awareness against drug abuse. Educational programs to prevent illicit drug use and the abuse of narcotic and psychotropic drugs and other addictive substances among students and young people have been launched across the country, distributing informative materials and encouraging healthy lifestyles without drugs. In 2023, over 100 million students from more than 230,000 schools throughout the country participated in the National Anti-drug Knowledge Competition, whose live final attracted an online audience of over 40 million viewers.
VII. Promoting Global Governance of
Fentanyl-Related Substances
Currently, the abuse of fentanyl-related substances is escalating globally. According to the United Nations Office on Drugs and Crime (UNODC) Early Warning Advisory, since 2013, 86 fentanyl analogues have been reported by 46 countries worldwide, accounting for 64 percent of the number of synthetic opioids reported. The World Drug Reports released by UNODC show that the number of fentanyl-related overdose deaths continues to increase in North America, and the trafficking of fentanyl-related substances has been occurring in Europe and other regions. According to data from the US Centers for Disease Control and Prevention, the number of overdose deaths involving synthetic opioids, primarily fentanyl-related substances, reached 75,000 in 2023, accounting for almost 70 percent of all drug overdose deaths, making fentanyl-related overdose the leading cause of death for adults aged 18 to 45 in the US. In 2022, EU countries reported seizures of 2.7 kilograms of fentanyl, 168 liters of liquid fentanyl, 8,435 fentanyl tablets, and 6.5 kilograms of carfentanil, with at least 163 deaths associated with the abuse of fentanyl-related substances.
Committed to the vision of a global community of shared future, China rigorously meets its international drug control obligations, and adheres to the principle of shared responsibilities among all countries and a comprehensive and balanced approach to drug control. It advocates mutual assistance, joint contribution, and shared benefit among all countries, and opposes finger-pointing and buck-passing. China honors its own drug control responsibilities, firmly upholds the existing international drug control system, participates fully in making important decisions on international drug control, and contributes Chinese wisdom and solutions to the global governance of drugs.
– Advancing bilateral and multilateral exchanges. China plays a positive role in jointly addressing new challenges in global drug governance, such as the fentanyl issue, through proactive cooperation with other countries and international organizations. It has signed 50 intergovernmental and interdepartmental documents on drug control cooperation with more than 30 countries and unions of countries, established annual meeting mechanisms with 13 countries, and joined multilateral drug control cooperation mechanisms within the Greater Mekong Subregion, the Shanghai Cooperation Organization, and BRICS. Through these efforts, China has consistently expanded all-round trust and cooperation with other countries in the field of drug control.
China has participated in a number of global endeavors for drug governance, including the UNODC’s Global Synthetics Monitoring: Analyses, Reporting and Trends (SMART) Programme, and the INCB’s two initiatives – Project ION (International Operations on New Psychoactive Substances) and the global Operational Partnerships to Interdict Opioid’s Illicit Distribution and Sales (OPIOIDS) Project. Through such endeavors, China has strengthened international exchanges on the types and trends of abuse of fentanyl-related substances and other synthetic drugs, dedicating itself to the collaborative efforts to address hotspot issues and pain points in international drug control.
– Promoting China-US cooperation on drug control. Drug law enforcement is a central focus of cooperation between China and the US. China upholds a clear and principled position on this matter: It is committed to cooperation based on equality and mutual respect, but firmly opposes the US imposition of unlawful sanctions and unreasonable pressure on China on the pretext of responding to fentanyl-related issues. The drug law enforcement agencies of both sides have jointly cracked major cases of smuggling, manufacturing, and trafficking, including the Wang Xi case and the Chen Ping case, and arrested relevant suspects in their respective territories and sentenced them in accordance with the law. These are all successful examples of cooperation between law enforcement agencies of the two countries.
On January 30, 2024, the China-US Counternarcotics Working Group held its first meeting in Beijing to identify priorities for counternarcotics cooperation. The two countries have since convened multiple high-level meetings to promote bilateral dialogue and cooperation in drug control and law enforcement. On July 31, 2024, an interdepartmental Chinese delegation visited the US to attend the first senior official meeting of the China-US Counternarcotics Working Group, building mutual trust in cooperation. The Narcotics Control Bureau of China’s Ministry of Public Security maintains daily hotline communication and holds regular exchange meetings with the US Department of Justice’s Drug Enforcement Administration, the US Department of Homeland Security’s Homeland Security Investigations, and other drug control agencies. Since 2024, with more than 100 instances of information exchange, the two sides have achieved breakthrough progress in the collaborative investigations of multiple transnational cases, including those concerning Du *gen, Tong *ji, and Huang *cheng.
– Strengthening precursor control. In compliance with international rules, China uses the INCB PEN Online system to strengthen international verification on key scheduled precursor chemicals, including precursors used to make fentanyl-related substances. It uses the INCB PEN Online Light system to strengthen verification and exchange information on non-scheduled precursor chemicals. To mitigate any risk of diversion, China actively participates in the INCB’s global precursor control initiatives, and conducts proactive international verification on certain precursor chemicals that are under its national control, but have not been scheduled internationally.
China advances the implementation of bilateral exchange and cooperation mechanisms on precursor chemicals with the European Union, Australia, and New Zealand, among others. In 2023, the China-Mexico Working Group on Precursor Chemicals was established to strengthen policy exchanges, share information, and carry out transnational law enforcement. This helps to curb the diversion of precursor chemicals while protecting lawful trade. On September 6, 2024, the working group convened its second meeting in Mexico City, and adopted its Rules of Operation and the meeting minutes, laying a solid foundation for China-Mexico cooperation in law enforcement, and exchange and cooperation concerning precursor chemicals and other substances.
– Conducting technological exchanges. To address the risks and challenges to global drug governance brought by fentanyl-related substances, China has carried out technological exchanges with the drug control agencies of various countries in order to share experience and practices in the testing and identification, monitoring of abuse, and assessment of hazards relating to fentanyl-related substances. It has held technical seminars on wastewater monitoring for fentanyl-related substances and other drugs, in exchanges with technical experts from UNODC, the European Monitoring Centre for Drugs and Drug Addiction (European Union Drugs Agency), Australia, New Zealand, and ASEAN countries. China has organized technical meetings and established a scientist exchange mechanism with the US, enabling the sharing of drug detection techniques and experience with drug control experts from the US Office of National Drug Control Policy, Drug Enforcement Administration, and Customs and Border Protection, among others. Since 2024, multiple exchanges have been conducted to promote technical cooperation and strengthen technical support in addressing the fentanyl issue.
Again, the above is an excerpt from the white paper "Controlling Fentanyl-Related Substances - China's Contribution". The full version:
