The time limit for submitting regular safety update reports for listed generic drugs is

1 year. According to the inquiry of Zhihu, the time period for submitting regular safety update reports for listed generic drugs is 1 year, and the reporting time of regular safety update reports is calculated from the date of obtaining the approval certificate. Domestic drugs with a new drug monitoring period shall submit a regular safety update report every 1 year from the date of obtaining the approval certificate.