The National Drug Administration issued a letter of consistency evaluation of chemical injections officially launched!

Today (May 14), the State Drug Administration issued the "State Drug Administration on the implementation of chemical injection sumobonomes quality and efficacy consistency evaluation work." Relevant interpretation is as follows:Answer: In order to implement the State Council's work on accelerating the implementation of the evaluation of the conformity of generic drugs, the State Drug Administration's Office of Conformity Conformity Evaluation organized a committee of experts to develop the "Chemical Injection Injection Imitation Drug Quality and Efficacy Conformity Evaluation Technical Requirements", "Chemical Injection (Special Injection) Imitation A series of documents, such as technical requirements for the evaluation of conformity evaluation of drug quality and efficacy, and the declaration data requirements for the conformity evaluation of the quality and efficacy of chemical injection sasia, were published after extensive consultation with the community and revised and improved, and officially launched the evaluation of the conformity of the quality and efficacy of chemical injection sinobs: The generic drugs of chemical injections that have been listed, and the varieties that have not been approved in accordance with the principle of conformity with the quality and efficacy of the original drugs, need to carry out a consistent evaluationThe holder of a drug listing license shall select the reference preparation according to the List of Generic Drug Reference Preparations issued by the State Drug Administration, and carry out a consistent evaluation of the research and development declarationhas not been included in the "generic drug reference preparation catalog" varieties, drug listing license holders should be in accordance with the "National Drug Administration on the issuance of chemical generic drug reference preparation selection and determination procedures" (No25 of 2019) to declare the reference preparations, pending the determination of the reference preparations to carry out a consistent evaluation of research and development declaration, to avoid the occurrence of reference preparation selection and national publication of the reference preparations, affecting the development of resources and other issuesa generic drug for chemical softos that are clearly of clinical value but cannot be determined, such as sodium chloride injections, glucose injections, sodium glucose chloride injections, and water injections, etc., does not require a consistency evaluationThe Office of Conformity Evaluation of Generic Drugs of the State Drug Administration will organize a committee of experts to comb and publish a catalogue of such varieties in stages, encourage drug market licensing holders to carry out research on drug quality improvement in accordance with the technical requirements for the quality and efficacy consistency evaluation of chemical injection strains, technical requirements for the quality and consistency of the quality and efficacy of generic drugs in chemical injections (special injections), and to report and implement the review time limit for consistency evaluation of drug market changes: According to the State Drug Administration on the quality and efficacy of similar drug consistency evaluation of matters (2018 No102) and other relevant provisionsin accordance with the Notice on Matters Related to the Conformity Evaluation of the Quality and Efficacy of Generic Drugs (No100 of 2017), the review shall be completed within 120 days of acceptanceIf, after the review, the applicant considers that additional information is required, the applicant shall complete the supplementary information at a one-time cost within 4 monthsThe time limit for the issuance of supplements shall not be included in the time limit for the review: Through the conformity evaluation of the variety, the drug regulatory authorities allow it to label and label it, and include it in the "new approved market ingress and through the quality and efficacy consistency evaluation of the chemical seology." Relevant departments will also give policy support in accordance with the "Opinions of the General Office of the State Council on the Conduct of Conformity Evaluation of the Quality and Efficacy of Generic Drugs" (State Office issued No8 of 2016)attached: According to the relevant provisions of the Opinions of the State Council on reforming the review and approval system of pharmaceutical medical devices (Guofa (2015) No 44), the Opinions of the General Office of the State Council on the Conduct of Conformity Evaluation of The Quality and Efficacy of Generic Drugs (No 8 of 2016), and the Announcement on Matters Related to the Conformity Evaluation of The Quality and Efficacy of Generic Drugs (No 102 of 2018), etc To speed up the evaluation of the consistency of generic drugs, the State Drug Administration decided to carry out the evaluation of the quality and efficacy of chemical injection sumobonoids (hereinafter referred to as the consistency evaluation of injections), and now announce the relevant matters as follows: , listed chemical injection generics, varieties that have not been approved in accordance with the principle of consistency with the quality and efficacy of the original drugs need to carry out a consistent evaluation The holder of a drug listing license shall select the reference preparation according to the List of Generic Drug Reference Preparations issued by the State Drug Administration, and carry out a consistent evaluation of the research and development declaration 2 The holder of the drug market ingenuity license shall carry out the research on the evaluation of the conformity of injections in accordance with the technical requirements for the conformity evaluation of the quality and efficacy of chemical injection generics and the technical requirements for the quality and efficacy of similar injections (special injections) and other relevant technical guidelines; , the Drug Enforcement Center shall conduct technical reviews in accordance with relevant regulations and technical guidelines, and initiate inspections based on the need for review The Centre for Drug ETrinos summarizes the review, inspection and inspection and forms a comprehensive review opinion If the comprehensive review is adopted, the drug review center shall issue a supplementary application for approval of the drug IV Other related matters not covered by this notice shall be implemented in accordance with the relevant provisions of the Notice on Matters Related to the Evaluation of Conformity Evaluation of the Quality and Efficacy of Generic Drugs (No 100 of 2017) This announcement shall be implemented from the date of publication this announcement ,000 May 12, 2020