【2018年整理】药品管理法.docVIP

Drug Control Law of the Peoples Republic of China (Adopted at the 7th Meeting of the Standing Committee of the Sixth National Peoples Congress on September 20, 1984; revised at the 20th Meeting of the Standing Committee of the Ninth National Peoples Congress on February 28, 2001 and promulgated by Order No.45 of the President of the Peoples Republic of China on February 28, 2001) Contents Chapter I General Provisions Chapter II Control over Drug Manufacturers Chapter III Control over Drug Distributors Chapter IV Control over Pharmaceuticals in Medical Institutions Chapter V Control over Drugs Chapter VI Control over Drug Packaging Chapter VII Control over Drug Pricing and Advertising Chapter VIII Inspection of Drugs Chapter IX Legal Liabilities Chapter X Supplementary Provisions Chapter I General Provisions Article 1 This Law is enacted to tighten drug control, to ensure drug quality and safety for human beings, to protect the health of people and their legitimate rights and interests in the use of drugs. Article 2 All institutions and individuals engaged in research, production, distribution, use, or control over drugs in the Peoples Republic of China shall abide by this Law. Article 3 The State develops both modern and traditional medicines to give full play to their role in prevention and treatment of diseases and in maintenance of health. The State protects the resources of natural crude drugs and encourages the cultivation of Chinese crude drugs. Article 4 The State encourages research and development of new drugs and protects the legitimate rights and interests of citizens, legal bodies and other institutions engaged in this field of endeavor. Article 5 The drug regulatory department under the State Council shall be responsible for drug regulation nationwide. The relevant departments under the State Council shall be responsible for the related regulatory work within the limits of their duties. The drug