1. Non-Clinical Research on humans is prohibited, and the Executive Regulations of this Decree-Law shall specify the controls for conducting non-Clinical Research. 2. It is prohibited to conduct any Clinical Trials before conducting non-clinical studies to initially confirm the degree of safety and effectiveness of the intended medical intervention from the clinical studies, with the exception of the compassionate use of the Medical Product in accordance with the controls specified in the Executive Regulations of this Decree-Law. 3. Clinical Research may be conducted in accordance with the terms, controls and procedures issued by the Cabinet.
Interpretation and application must be checked against the official text and current version.