Chang Weihong, deputy director of the Biological Products Department of the State Food and Drug Administration Registration Department, said recently，The Drug Administration has initiated the relevant work of formulating a guide to formulating biological generic drugs，Currently in the investigation stage，Hope scientists in the front line、Entrepreneurs can actively participate，Help the development of work。
 
There is no way and standards for domestic enterprises to report biotechnology.，Chang Weihong thinks，In the current registered management framework, it is not without such a way and standards。Many previous products stake betting appare listed，All are in accordance with the procedures and regulations，Reference to the standard declaration and approval。but but，No technical requirements and quality control management regulations specifically for bio -generating drugs。
 
Current，The Registration Division of the State Drug Administration has initiated the preliminary work formulated by the biotechnology guide，Ready to take a survey、Draft、Method of implementing three steps。The research work has been started，and prepared four working groups，Including policy、Quality Control、Dormation of clinical research and clinical research，It is planned to establish a scientist、Researcher、A consultant team composed of entrepreneurs at home and abroad。
 
Chang Weihong said，The formulation of the guide may encounter a relatively large challenge，For example, the control product setting、Technical Questions、Difficulties and benefits of similarity and benefits of similarity。But，The overall attitude is to do，Methods need to be cautious。