Announcement of the State Drug Administration on the consistent evaluation of the quality and efficacy of chemical injection generics (No. 62 of 2020)

According to the "State Council on the reform of Drug and Medical Device review and approval system view" (Guo Fa [2015] No44), "the State Council on the quality and efficacy of generic drugs to carry out conformity assessment opinions" (Guo Ban Fa [2016] 8 No.) "Notice on the quality and efficacy of generic drugs to evaluate the agreement related matters" (2018, No102) and other relevant provisions, in order to accelerate generic consistency evaluation, the State drug Administration decided to carry out chemical injection simulation pharmaceutical quality consistency and efficacy evaluation (hereinafter referred to as the conformance assessment injection), the relevant matters are announced as follows:a, listed chemicals injection generic, not in accordance with the principles of the approval is consistent with the original study drug quality and efficacy consistency breeds are required to carry out the evaluationMarketing authorization holder shall select based on national and Drug Administration issued a "generic reference formulation Directory" reference preparation, and conduct research and development to declare conformance assessmenttwo, marketing authorization holder shall "generic quality consistency and efficacy evaluation techniques requires chemical injection" in accordance with "chemical injection (special injection) quality and efficacy of generic technical requirements conformance evaluation" like evaluation of injection principle conduct related to the consistency of technical guidance; accordance with the "quality and efficacy of generic drugs to evaluate the agreement chemical injection disclosure of information requirements" written disclosure of information, and to pharmaceutical supplementary application form to the national Center for drug evaluation and drug Administration ( hereinafter referred to as drug trial center) proposed to evaluate the agreement apply injectionIII drug trial center to carry out the technical review in accordance with relevant laws and regulations and technical guidelines, based on the need to initiate a review of inspection and examinationDrug trial centers summary of the review, inspect and examine the situation and to form a comprehensive review of the opinionThrough a comprehensive review of pharmaceutical drug trial center issued a supplementary application documentFourth, other related matters not covered in this announcement refer to "Notice related matters conformance assessment work on the quality and efficacy of generic drugs" (2017, No100) the relevant regulationsThis announcement from the date of promulgationherebySFDA2020 May 12