Henan issued opinions to carry out the consistency evaluation of generic drugs in a scientific and standardized way

[policies and regulations of China Pharmaceutical network] in order to promote the evaluation of quality and efficacy consistency of generic drugs, Henan issued the implementation opinions on promoting the evaluation of quality and efficacy consistency of generic drugs, which put forward that it will focus on five tasks: publicity and training, sorting out and optimizing resources, building support system, accelerating acceptance and evaluation, and implementing main responsibility In order to promote the structural adjustment, transformation and upgrading of the pharmaceutical industry in Henan Province, the general office of Henan provincial government recently issued the implementation opinions on promoting the consistency evaluation of quality and efficacy of generic drugs (hereinafter referred to as "implementation opinions"), which requires the full implementation of relevant national requirements, and encourages and guides pharmaceutical manufacturers to carry out consistency evaluation on generic drugs approved for listing before the implementation of new registration and classification of chemicals Complete the evaluation of generic drugs approved before 2007 by the end of the year According to the implementation opinions, for the chemical generic oral solid preparations approved for marketing before October 1, 2007 in the National Essential Drug Catalogue (2012 Edition), the conformity evaluation shall be completed by the end of 2018, among which the clinical effectiveness test and the varieties with special circumstances shall be completed by the end of 2021; For other generic drugs approved for listing before the implementation of the new registration and classification of chemical drugs, after the first varieties pass the consistency evaluation, the consistency evaluation of the same varieties of other drug manufacturers shall be completed within 3 years in principle; the consistency evaluation of other drug varieties shall be accelerated to promote the healthy and rapid development of the pharmaceutical industry In order to promote the consistency evaluation of quality and efficacy of generic drugs, the "green" channel for resource optimization and evaluation is proposed in the implementation opinions, which focuses on five tasks: publicity and training, resource optimization, building support system, accelerating acceptance and evaluation, and implementing the main responsibility In the aspect of sorting out and optimizing resources, the approval numbers of drug manufacturers and chemical oral solid preparations involved in the consistency evaluation were investigated, and the information of intention to carry out the consistency evaluation was summarized Build a platform for consistency evaluation and technology transfer of drug varieties, and make use of market mechanism to optimize resource allocation on the basis of enterprises' willingness In terms of building support system, fully integrate the technical strength of Zhengzhou University, Henan University, Xinxiang Medical College and other universities, relevant scientific research institutes and drug related inspection and testing institutions, and provide inspection and testing and technical consultation services for enterprises to carry out consistency evaluation Guide the qualified medical institutions in our province to actively participate in the clinical trials of conformity assessment drugs, and give priority to the clinical trials of conformity assessment of drug manufacturers in our province The Implementation Opinions also proposed to improve the working mechanism of policy consultation, technical support and clinical trial service for consistency evaluation, establish a "green" channel for consistency evaluation, and optimize the workflow of on-site inspection, data acceptance, data collection and submission Increase policy support and reward 1 million yuan for passing evaluation on schedule According to the implementation opinions, for the drug varieties that have passed the consistency evaluation in our province, drug manufacturers can mark them in the drug instructions and labels, give priority to adjusting the drug catalog of medical insurance, provide support in the aspect of medical insurance payment, give priority to the range of purchased varieties in the volume purchase of drugs, give priority to the selection in the bidding purchase of drugs and clinical medication Priority should be given to the use of drugs that have passed the consistency evaluation of the province The provincial finance will give a one-time reward of 1 million yuan to the top three enterprises that have passed the consistency evaluation and those that have passed the evaluation on schedule For the production enterprises that pass the consistency evaluation, encourage the cities under the jurisdiction of each province and the counties (cities) directly under the jurisdiction of each province to formulate supporting policies and give corresponding rewards Original title: Henan issued opinions to promote the consistency evaluation of quality and efficacy of generic drugs