In order to meet the needs of the research and development of new vaccines of China, standardize and offer guidance to the new vaccine research and development, the State Food and Drug Administration (SFDA) organized the revision of the Technical Guideline for Pre-Clinical Research of Preventive Vaccines based on China’s actual situation of vaccine research and technical review. Technical Guideline for Pre-Clinical Research of Preventive Vaccines was issued recently. It is only applicable to the preventive vaccines prepared by traditional methods (inactivation, attenuation, separation and extraction), and is to provide principles to the pre-clinical research of preventive vaccines. |