Measures of the Chinese People's Liberation Army for Implementing the Medicinal Product Administration Law of the People's Republic of China (2025 Revision)

Measures of the Chinese People's Liberation Army for Implementing the Medicinal Product Administration Law of the People's Republic of China (2025 Revision)

Order of the State Council of the People's Republic of China and the Central Military Commission of the People's Republic of China
(No. 805)

The revised Measures of the Chinese People's Liberation Army for Implementing the Medicinal Product Administration Law of the People's Republic of China are hereby announced and shall come into force on June 1, 2025.

Xi Jinping, Chairman of the Central Military Commission
Li Qiang, Premier of the State Council
April 5, 2025

Measures of the Chinese People's Liberation Army for Implementing the Medicinal Product Administration Law of the People's Republic of China
(Issued by Order No. 425 of the State Council of the People's Republic of China and the Central Military Commission of the People's Republic of China on December 9, 2004 and revised by Order No. 805 of the State Council of the People's Republic of China and the Central Military Commission of the People's Republic of China on April 5, 2025)

Chapter I General Provisions
Article 1 These Measure are developed in accordance with the Medicinal Product Administration Law of the People's Republic of China and other relevant laws and regulations for the purpose of strengthening the administration of medicinal products in the armed forces.
Article 2 These Measures shall apply to the activities of research and development, production (including preparation), reserve, supply, use, supervision and administration of medicinal products in the armed forces.
Article 3 The administration of medicinal products in the armed forces shall insist on the leadership of the Communist Party of China, implement Xi Jinping's thinking on strengthening military, insist on the principles of risk management, full-process control, and military-civilian coordination, and conduct scientific and strict regulation to ensure safety, effectiveness, and accessibility of medicinal products.
Article 4 Under the leadership of the Central Military Commission, the Logistics Support Department of the Central Military Commission shall be responsible for organizing and guiding the supervision and administration of medicinal products in the armed forces. The specific work shall be undertaken by the business department in charge of the health work of the Logistics Support Department of the Central Military Commission. Other departments of the Central Military Commission shall, in accordance with their respective duties, effectively complete the supervision and administration work concerning medicinal products.
The Logistics Support Departments of military entities at or above the regimental level shall be responsible for the supervision and administration of medicinal products within their systems and entities, as well as the response to safety emergencies of medicinal products; and other departments of the organs at the same levels shall, in accordance with their respective duties, effectively complete the supervision and administration work concerning medicinal products.
Article 5 The business department of the Logistics Support Department of the Central Military Commission responsible for the health work shall establish a working coordination mechanism for registration review, joint regulation, professional training and information notification, and carry out supervision and administration of medicinal products in a coordinated manner with the medical products administrative department of the State Council, and the medical products administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
The medical products administrative department of the State Council and the departments of the people's governments at or above the county level that undertake the duties of supervision and administration of medicinal products shall perform corresponding duties of supervision and administration of medicinal products in accordance with the provisions of these Measures.
Article 6 Military pharmaceutical technical institutions shall, in accordance with the law, undertake the review, inspection, verification, monitoring, evaluation and other work required for the supervision and administration of medicinal products in the armed forces.
Article 7 Military entities shall strengthen management in accordance with the relevant national and military standards and norms for traceability of medicinal products to achieve traceability of medicinal products.
Military entities shall, in accordance with the relevant rules of the state and the armed forces on pharmacovigilance, monitor, identify, assess and control adverse drug reactions of medicinal products and other harmful reactions related to the use of medicinal products.
Article 8 Entities and individuals that have made outstanding contributions to the research and development, production, reserve, supply, use, supervision and administration of medicinal products in the armed forces shall be commended and rewarded in accordance with the relevant rules of the state and military regulations.
Chapter II Reserves and Supply of Medicinal Products
Article 9 The armed forces shall implement a system for the reserve of medicinal products for combat readiness.
The Logistics Support Department of the Central Military Commission and relevant ministries and commissions of the State Council shall establish a collaborative mechanism for the transfer of medicinal products of the armed forces for combat readiness and from the national reserve for the urgent needs to ensure the emergency use of medicinal products in case of war, major disasters, epidemics or other emergencies.
Article 10 The armed forces shall prepare a list of essential military medicinal products, enhance the reserve and supply capacity of essential medicinal products, and meet the basic needs for the use of medicinal products for the prevention and treatment of injuries and illnesses of military personnel.
Article 11 Military medical institutions and medicinal material supply guarantee institutions shall purchase medicinal products from medicinal products marketing authorization holders (“MAHs”) or enterprises qualified for the production or distribution of medicinal products, except for the purchase of traditional Chinese medicinal materials not subject to approval management.
Article 12 Military medical institutions and medicinal material supply guarantee institutions shall establish and implement a system for inspection and acceptance of goods purchased when purchasing medicinal products, verify the qualification certificates and other labels of medicinal products, and have authentic, complete and traceable purchase records of medicinal products.
The purchase record of medicinal products shall indicate the medicinal product's generic name, dosage form, specification, batch number of the product, expiration date, MAH, manufacturer, supplier, purchase quantity, purchase price, purchase date and other relevant contents as prescribed by the medical products administrative department of the State Council.
Military medical institutions and medicinal material supply guarantee institutions shall develop and implement the rules for the safekeeping of medicinal products, and adopt cooling, freeze-proof, moisture-proof, insect-proof, rodent-proof, and other necessary measures to assure quality of medicinal products.
Article 13 Military medicinal materials supply guarantee institutions shall, in accordance with the designated areas and assigned tasks, be responsible for the supply guarantee of medicinal products needed by military entities.
Military medicinal material supply guarantee institutions shall not supply medicinal products to civilian entities and personnel. In the event of major disasters, epidemics or other emergencies, if it is truly necessary to supply to civilian entities and personnel, approval of the Logistics Support Department of the Central Military Commission shall be obtained.
Article 14 A military medicinal materials supply guarantee institution carrying out medicinal materials supply guarantee activities shall obtain a license for supply of military medicinal materials issued by the business department of the Logistics Support Department of the Central Military Commission responsible for the health work. Medicinal products shall not be supplied without a license for the supply of military medicinal materials.
Article 15 Vaccines needed to be received by military personnel shall be purchased by the military disease prevention and control institutions from vaccine MAHs through the vaccine procurement channels prescribed by the state. Vaccines not included in the procurement organized by the state may be purchased from vaccine MAHs in accordance with the relevant regulations on military procurement. A vaccine MAH shall supply vaccines to military disease prevention and control institutions or military entities designated thereby as agreed in the procurement contracts.
The military disease prevention and control institutions and other relevant military entities engaged in vaccine storage and transportation activities shall strictly abide by the relevant regulations of the state and ensure the quality of vaccines.
Chapter III Pharmaceutical Administration of Military Medical Institutions
Article 16 A military medical institution shall appoint pharmacists or other pharmaceutical technicians who have been qualified by the state or the armed forces, and be responsible for the management of medicinal products, prescription review and dispensing, and guidance on rat......