[just] CDE: Notice on matters related to chemical generic reference preparation under review

At present, among the varieties of registration classification 3, 4, 5.2 and conformity evaluation of chemical generic drugs being reviewed by the drug Audit Center, there is a situation that the selected reference preparation is not in the list of reference preparation issued by the State Drug Administration In order to optimize the connection process of review and selection of reference preparation and improve the efficiency of review, the relevant matters are hereby notified as follows: 1、 It is suggested that the applicant should apply for the selection of reference preparations through the reference preparation application platform as early as possible when initiating the generic drug research 2、 If the reference preparation selected in the examination is not in the catalogue of reference preparation issued by the State Drug Administration, the applicant is requested to apply for the selection of reference preparation on the application platform of reference preparation as soon as possible Drug evaluation center of SDA August 5, 2019