Biological immunotherapy is a popular medical research, and its regulatory issues occur into public view because of the Wei Zexi event. From the initial approval system to the current record-keeping system, biological therapy has actually been in a “zero” state of supervision. Its discretion rests from research to clinical application are in the hands of the hospital, which causing a lot of social problems. A good state regulation is beneficial to scientific progress, especially in the medical field which related to the life and health of citizen. It is very crucial. In this paper, we combine the status quo of legislative experiences at home and abroad to research the better regulatory path of biological therapy that suited to China.