Source: Center for Drug Evaluation of the State Drug Administration Date:20230106

       In order to promote the smooth implementation of the newly revised ICH guidelines in China, the Center has formulated the implementation proposal of "E19: Selective Collection of Safety Data in Specific Late Pre-market or Post-market Clinical Trials", and at the same time organized the translation of the Chinese version. The E19 implementation proposal and the Chinese version are now open for comments for one month.

       If you have any modifications, please send your feedback to the contact person's e-mail address: gkzhqyj@cde.org.cn.

       Attachment: 1. E19 Implementation Proposal

                 2.E19 Chinese version

                 3.E19 English version

                                                                                                         Center for Drug Evaluation, State Drug Administration

                                                                                                                        January 6, 2023