legal ground
Article 30 of the Regulations for the Implementation of the Drug Administration Law
The development of new drugs requires clinical trials, which shall be approved by the drug supervision and administration department of the State Council in accordance with the provisions of Article 29 of the Drug Administration Law.
After the drug clinical trial application is approved by the drug supervision and administration department of the State Council, the applicant shall choose the institution that undertakes the drug clinical trial among the legally recognized institutions with the qualification for drug clinical trial, and report the clinical trial institution to the drug supervision and administration department of the State Council and the health administrative department of the State Council for the record.
Drug clinical trial institutions shall inform the subjects or their guardians of the real situation in advance and obtain their written consent when conducting drug clinical trials.