Drug Administration Law of the People's Republic of China (Revised in 2019)
Drug Administration Law of the People's Republic of China (Revised in 2019)
Drug Administration Law of the People's Republic of China (Revised in 2019)
Order of the President of the People's Republic of China No. 31
August 26, 2019
The Drug Administration Law of the People's Republic of China, which was revised and adopted at the 12th Session of the Standing Committee of the 13th National People's Congress of the People's Republic of China on August 26, 2019, is hereby promulgated and shall come into effect as of December 1, 2019.
Xi Jinping, President of the People's Republic of China
Drug Administration Law of the People's Republic of China (Revised in 2019)
(Adopted at the Seventh Session of the Standing Committee of the Sixth National People's Congress on September 20, 1984; revised for the first time at the 20th Session of the Standing Committee of the Ninth National People's Congress on February 28, 2001; amended for the first time in accordance with the Decision on Amending Seven Laws Including the Marine Environment Protection Law of the People's Republic of China adopted at Sixth Session of the Standing Committee of the 12th National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision on Amending the Drug Administration Law of the People's Republic of China adopted at the 14th Session of the Standing Committee of the 12th National People's Congress on April 24, 2015; revised for the second time at the 12th Session of the Standing Committee of the 13th National People's Congress on August 26, 2019)
Contents
Chapter I General Provisions
Chapter II Drug Development and Registration
Chapter III Drug Marketing License Holder
Chapter IV Drug Production
Chapter V Drug Distribution
Chapter VI Drug-related Affairs Management in Medical Institutions
Chapter VII Post-marketing Drug Management
Chapter VIII Drug Prices and Advertising
Chapter IX Drug Reserve and Supply
Chapter X Supervision and Management
Chapter XI Legal Liability
Chapter XII Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated with a view to strengthening drug management, ensuring drug quality, guaranteeing the public’s drug use safety and legitimate rights and interests and protecting and promoting public health.
Article 2 This Law shall apply to those engaging in such activities as drug development, production, distribution, use, supervision and management within the territory of the People's Republic of China (hereinafter referred to as the "PRC").
For the purpose of this Law, drug refers to any substance used for preventing, treating and diagnosing human diseases as well as purposely regulating human physiological functions with specified indications or functions, usage and dosage, including traditional Chinese medicines (hereinafter referred to as "TCM"), chemical drugs and biological products.
Article 3 Drug management shall center on the people's health, adhere to principles of risk management, whole-process management and control and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve drug quality and ensure the safety, efficacy and accessibility of drugs.
Article 4 The State develops both modern and traditional drugs to give full play to the roles thereof in disease prevention, medical treatment and healthcare.
The State protects wild medicinal material resources and TCM varieties, and encourages the cultivation of natively genuine TCM materials.
Article 5 The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations engaging in this field of endeavor.
Article 6 The State implements a drug marketing license holder system for drug management. Drug marketing license holders shall, in accordance with the law, be responsible for the safety, efficacy and quality controllability of drugs throughout the whole process involving drug development, production, distribution and use.
Article 7 Whoever engages in drug development, production, distribution and use activities shall abide by laws, regulations, rules, standards and practices, and ensure the authenticity, accuracy, completeness and traceability of information throughout the whole process.
Article 8 The medical products administration under the State Council shall be responsible for drug supervision and management nationwide.
......
Order of the President of the People's Republic of China No. 31
August 26, 2019
The Drug Administration Law of the People's Republic of China, which was revised and adopted at the 12th Session of the Standing Committee of the 13th National People's Congress of the People's Republic of China on August 26, 2019, is hereby promulgated and shall come into effect as of December 1, 2019.
Xi Jinping, President of the People's Republic of China
Drug Administration Law of the People's Republic of China (Revised in 2019)
(Adopted at the Seventh Session of the Standing Committee of the Sixth National People's Congress on September 20, 1984; revised for the first time at the 20th Session of the Standing Committee of the Ninth National People's Congress on February 28, 2001; amended for the first time in accordance with the Decision on Amending Seven Laws Including the Marine Environment Protection Law of the People's Republic of China adopted at Sixth Session of the Standing Committee of the 12th National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision on Amending the Drug Administration Law of the People's Republic of China adopted at the 14th Session of the Standing Committee of the 12th National People's Congress on April 24, 2015; revised for the second time at the 12th Session of the Standing Committee of the 13th National People's Congress on August 26, 2019)
Contents
Chapter I General Provisions
Chapter II Drug Development and Registration
Chapter III Drug Marketing License Holder
Chapter IV Drug Production
Chapter V Drug Distribution
Chapter VI Drug-related Affairs Management in Medical Institutions
Chapter VII Post-marketing Drug Management
Chapter VIII Drug Prices and Advertising
Chapter IX Drug Reserve and Supply
Chapter X Supervision and Management
Chapter XI Legal Liability
Chapter XII Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated with a view to strengthening drug management, ensuring drug quality, guaranteeing the public’s drug use safety and legitimate rights and interests and protecting and promoting public health.
Article 2 This Law shall apply to those engaging in such activities as drug development, production, distribution, use, supervision and management within the territory of the People's Republic of China (hereinafter referred to as the "PRC").
For the purpose of this Law, drug refers to any substance used for preventing, treating and diagnosing human diseases as well as purposely regulating human physiological functions with specified indications or functions, usage and dosage, including traditional Chinese medicines (hereinafter referred to as "TCM"), chemical drugs and biological products.
Article 3 Drug management shall center on the people's health, adhere to principles of risk management, whole-process management and control and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve drug quality and ensure the safety, efficacy and accessibility of drugs.
Article 4 The State develops both modern and traditional drugs to give full play to the roles thereof in disease prevention, medical treatment and healthcare.
The State protects wild medicinal material resources and TCM varieties, and encourages the cultivation of natively genuine TCM materials.
Article 5 The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations engaging in this field of endeavor.
Article 6 The State implements a drug marketing license holder system for drug management. Drug marketing license holders shall, in accordance with the law, be responsible for the safety, efficacy and quality controllability of drugs throughout the whole process involving drug development, production, distribution and use.
Article 7 Whoever engages in drug development, production, distribution and use activities shall abide by laws, regulations, rules, standards and practices, and ensure the authenticity, accuracy, completeness and traceability of information throughout the whole process.
Article 8 The medical products administration under the State Council shall be responsible for drug supervision and management nationwide.
......