Drug Administration Law of the People's Republic of China (Закон Китайской Народной Республики «О контроле над медикаментами») (по состоянию на 26.08.2019 г.)
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Drug Administration Law of the People's Republic of China
(Закон Китайской Народной Республики «О контроле над медикаментами»)
(по состоянию на 26.08.2019 г.)
(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984; revised for the first time at the 20th Meeting 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 Revising Seven Laws Including the Marine Environmental Protection Law of the People's Republic of China adopted at the 6th Meeting of the Standing Committee of the Twelfth National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision on Revising the Drug Administration Law of the People's Republic of China adopted at the 14th Meeting of the Standing Committee of the Twelfth National People's Congress on April 24, 2015; revised for the second time at the 12th Meeting of the Standing Committee of the Thirteenth National People's Congress on August 26, 2019)
Chapter II Research and Development and Registration
Chapter III Marketing Authorization Holder
Chapter VI Pharmacy Administration in Medical Institutions
Chapter VII Post-marketing Management
Chapter VIII Pricing and Advertising
Chapter IX Stockpile and Supply
Chapter XII Supplementary Provisions
Article 1 This Law is enacted to strengthen drug administration, ensure drug quality, protect drug safety and legitimate rights and interests of the public, and protect and promote public health.
Article 2 This Law shall apply to activities involving drug development, manufacturing, distribution, and use, and drug regulation in the territory of the People's Republic of China.
Drugs in this Law refer to substances used in the prevention, treatment, and diagnosis of human diseases and intended for the physiological regulation of the body's functions, for which indications or functions, dosage, and administration are stipulated, including traditional Chinese medicines, chemical drugs and biological products.
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