Abstract: This paper systematically reviewed laws and regulations in our country, relevant guidelines of ICH and ISPE, analyzed six different sources of adverse drug reactions/ adverse events, such as spontaneous reports, sourced from organized data collection scheme,literature,abroad, contractual agreements and other sources, put forward the minimum data elements, contents and time frames of individual report,specific reporting requirements of those sourced from organized data collection scheme and abroad,and put emphasis on the requirements on how to analyze individual report in summary report. It’s aimed to provide reference for manufacturers according to reporting requirements.

Key words: manufacturer, adverse drug reaction(ADR), adverse event, reporting requirements