The legislative purpose of the Drug Administration Law is to strengthen drug supervision and management, ensure the quality of drugs, ensure the safety of human drug use, and safeguard people's health and the legitimate rights and interests of drug use. The scope of application is that all units or individuals engaged in drug research, production, management, use, supervision and management within the territory of People's Republic of China (PRC) must abide by this Law. Those who produce and sell drugs without obtaining the Pharmaceutical Production and Business License or the Pharmaceutical Preparation License for Medical Institutions shall be banned, the drugs and illegal income shall be confiscated, and a fine of more than 2 times and less than 5 times the value of the drugs shall be imposed; If a crime is constituted, criminal responsibility shall be investigated according to law. Those who provide false certificates, documents, samples or obtain licenses for drug production, trading and use or other drug approval documents by other deceptive means shall have their licenses revoked or their drug approval documents revoked, and their applications shall not be accepted within five years, and they shall also be fined between 654.38 million yuan and 30,000 yuan.

legal ground

Drug Administration Law of People's Republic of China (PRC) Article 1 This Law is formulated with a view to strengthening drug supervision and administration, ensuring drug quality, ensuring the safety of human drug use, and safeguarding people's health and the legitimate rights and interests of drug use.

Article 2 Units or individuals engaged in drug research, production, trading, use, supervision and management within the territory of People's Republic of China (PRC) must abide by this Law.

Article 5 The drug supervision and administration department of the State Council is in charge of drug supervision and administration throughout the country. The relevant departments of the State Council are responsible for drug supervision and administration within their respective functions and duties. The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the pharmaceutical supervisory and administrative work within their respective administrative areas. The relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for drug supervision and administration within their respective functions and duties.

The drug supervision and administration department of the State Council shall cooperate with the comprehensive economic department of the State Council to implement the development plan and industrial policy of the pharmaceutical industry formulated by the state.