Legal basis: Drug Administration Law of People's Republic of China (PRC).
Article 20 When setting up a preparation room, a medical institution shall submit an application to the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and submit it to the pharmaceutical supervisory and administrative department of the people's government at the same level for examination and approval. If the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government pass the inspection, they shall be approved and issued a Pharmaceutical Preparation License for Medical Institutions.
The health administrative departments and drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision of approval or disapproval within 30 working days from the date of receiving the application.
Twenty-eighth drug non-clinical safety evaluation and research institutions must implement the "quality management standards for drug non-clinical research", and drug clinical trial institutions must implement the "quality management standards for drug clinical trials". The Quality Management Standard for Non-clinical Research of Drugs and the Quality Management Standard for Clinical Trial of Drugs were formulated by the drug supervision and administration department of the State Council in consultation with the administrative department of science and technology of the State Council and the administrative department of health of the State Council respectively.
Article 56 The pharmaceutical supervisory and administrative department (including the pharmaceutical supervisory and administrative institution established by the pharmaceutical supervisory and administrative department of the provincial people's government according to law, the same below) shall supervise and inspect the development, production, marketing and use of drugs according to law.