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

On May 14, the State Drug Administration issued the "Announcement of the State Drug Administration on the consistent evaluation of the quality and efficacy of chemical injection generics." Related interpretation is as follows:, "the State Drug Administration on the development of chemicalinjection sumobonomes quality and efficacy consistency evaluation of the results of the announcement" is the background?Answer: In order to implement the work of the State Council on accelerating the evaluation of the conformity of generic drugs, the State Drug Administration's Office of Conformity Evaluation of Generic Drugs organized a committee of experts to formulate the Technical Requirements for The Conformity Evaluation of The Quality and Efficacy of Chemical Injection Siubos, and The Drug Injection (Special Injection) Generic Sinopia A series of documents, such as the technical requirements for conformity evaluation of quality and efficacy, and the declaration data requirements for the quality and efficacy consistency of chemical injection scopies, were published after extensive consultation with the community and revised and improved, and officially launched the evaluation of the quality and efficacy consistency of chemical injection genericsII, chemical injection suking of the object of the consistency evaluation of what?Answer: 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, require 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 yet 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 resourcesa 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, which do 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 changesA: 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 months The time limit for the issuance of supplements shall not be included in the time limit for the review five, through the consistency of the evaluation of varieties, continue to enjoy the relevant policy support? answer: Through the consistency evaluation of the variety, the drug regulatory authorities allow edgand slots and labels, and include it in the "new approved marketing 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 No 8 of 2016) in accordance with the relevant provisions of the State Council's Opinions on reforming the review and approval system of drug (No 44 of The State Council 2015), the Opinions of the General Office of the State Council on the Consistent Evaluation of the Quality and Efficacy of Generic Drugs (No 8 of 2016), and the Notice on Matters Related to the Conformity Evaluation of The Quality and Efficacy of Generic Drugs (No 102 of 2018), In order 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 stakes in the drug market shall conduct a study on the conformity evaluation of injections in accordance with the technical requirements for the conformity evaluation of the quality and efficacy of chemical injection sumosomes and the technical requirements for the conformity evaluation of generic drugs for chemical injections (special injections) and other relevant technical guidelines; iii, the Drug Etrino Center shall conduct technical reviews in accordance with the relevant 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 Similar Drugs (No 100 of 2017) This announcement shall be implemented from the date of publication this announcement National Drug Administration
May 12, 2020