Answer： This paragraph raises two questions: 1. Is the BE trial a non therapeutic trial? When does a non therapeutic trial require the subject to sign the ICF in person? First question: BE test ≠ non therapeutic test. The two are classified from different levels of clinical trials. Most of the BE tests are for healthy subjects, but they can also be grouped into special patient groups for research according to research purposes (such as hepatitis, AIDS, cancer, etc.), so the BE test can be either therapeutic or non therapeutic. The second question can be answered from the two ICH GCP principles cited in the article: If a non therapeutic trial meets the five requirements listed in 4.8.14 simultaneously, the trial is allowed to be conducted after obtaining an ICF signed by the legal representative of the subject, otherwise both require obtaining an ICF signed by the subject himself. In addition, the expanded knowledge of the requirement for non subject individuals to sign ICF can refer to 4.8.12, 4.8.15, and 21 CFR Part 50 in the ICH GCP.