Legal basis: Article 2 of the Drug Administration Law of People's Republic of China (PRC) shall abide by the quality management standards for non-clinical research and clinical trials of drugs, and ensure that the whole process of drug research and development continues to meet legal requirements. To carry out non-clinical research on drugs, it should comply with the relevant provisions of the state, have personnel, venues, equipment, instruments and management systems suitable for the research project, and ensure the authenticity of relevant data, materials and samples. To carry out clinical trials of drugs, relevant data, materials and samples such as research methods, quality indicators, pharmacological and toxicological test results shall be truthfully submitted in accordance with the provisions of the drug supervision and administration department of the State Council, and approved by the drug supervision and administration department of the State Council. Drugs listed in China shall be approved by the drug supervision and administration department of the State Council and obtain the Drug Registration Certificate.