Abstract: Objective To provide thoughts and references for improving vaccine post-marketing surveillance in China. Methods Through introducing the experiences of other countries and analyzing the situation in China, to find the gap between China and advanced countries in vaccine post-marketing surveillance. Results Active surveillance is one of the import methods of post-marketing safety monitoring of vaccine. Using active surveillance, it is not only to ascertain the potential signals detected from passive surveillance data, but also to verify the safety hypothesis by combining proper epidemiological study. Conclusion Vaccine active surveillance in China is still in its infancy. Vaccine pharmacovigilance system should be strengthened according to our own situation by using international advanced experience, utilizing existing data platform and information technique, and establishing long-term cooperation partnership with research institutions.

Key words: vaccine, passive surveillance, active surveillance