A reply from the General Division of the State Drug Administration on the identification of raw materials and drugs in the newly revised Drug Administration Law and the application of relevant laws.

Introduction: The API is still in accordance with the drug management, should abide by the provisions of the Drug Administration Law!----- Shandong Provincial Drug Administration: Your Bureau's "Request s/, after study, the present letter is as follows: First, the Report of the Constitution and Law Committee of the National People's Congress on The Law of the People's Republic of China on the Drug Administration Law (Amendment Draft) of the People's Republic of China, which states that the revised draft will summarize the types of drugs in the definition of medicines in accordance with the classification of drugs recognized by all partiesthe raw materials are still in accordance with the drug management, should abide by the provisions of the Drug Administration LawOn the application of Article 124 of the New Drug Administration Law, the New Drug Administration Law redefines counterfeit and inferior drugs mainly in accordance with the efficacy of drugs, and the State Council in the case of the former Drug Administration Law "in accordance with the theory of counterfeit drugs" and "in accordance with the theory of inferior drugs" Drugs prohibited by the drug supervision and administration department, drugs that must be approved and produced and imported without approval, must be tested and sold without inspection, and drugs produced with out-of-approval raw materials must be used, and separate provisions are made, which expressly prohibit the production, import, sale and use of these drugs, and providefor administrative responsibility in Article 124in the supervision and enforcement, if it discovers that unauthorized drugs, the use of raw materials produced drugs without review and approval and other illegal circumstances, can not simply apply Article 124, should be comprehensive case, to determine whether there are non-drug posing drugs, with such drugs posing as other drugs, the use of raw materials whether the pharmaceutical requirements, and other illegal circumstances, constitute a counterfeit drug or the sale of counterfeit drugs, shall be in accordance with the production, import, sale of counterfeit drugs and other illegal circumstancesThe Legislative Law on "from the old and the light" provides that laws, administrative regulations, local regulations, autonomous regulations and individual regulations and regulations are not retroactive, except for special provisions made to better protect the rights and interests of citizens, legal persons and other organizationsif the new law is discovered or investigated for any illegal act committed before the implementation of the new law, the administrative organ shall, when carrying out administrative punishment for the violation, make a comparative analysis of the administrative punishment in the old and new laws and select the legal provisions that are beneficial to the relative personthe investigation and prosecution of specific cases of the production of pharmaceutical drugs using raw materials without review and approval, the administrative organ shall make a comprehensive judgment on the meritsthe act is suspected of committing a crime, it shall be transferred to a judicial organ in accordance with the lawIf thediscovers that the upstream production and operation enterprises are suspected of committing illegal crimes, they shall promptly notify the relevant local regulatory authorities of the relevant clues(1) If an API is found in the supervision and inspection without review and approval, the act of the supplier or preparation manufacturer of the API shall be comprehensively determined and dealt with according to law, in combination with the source of the API and the test results(ii) According to the provisions of the Criminal Law, as long as the intentional commission of illegal acts in the production and sale of counterfeit drugs, it shall be investigated for criminal responsibilitydoes not constitute the crime of producing and selling counterfeit drugs does not mean that the illegal act does not constitute a crime;the Integrated Division of the National Drug Administration on July 3, 2020.