Beijing new pharmaceutical industry: taking off twice by consistency evaluation

          It is an important task of the 12th Five Year Plan for national drug safety to carry out the evaluation of the consistency of quality and efficacy of generic drugs and comprehensively improve the quality of generic drugs According to the relevant requirements of the notice of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs (GBF [2016] No 8), October 1, 2007 is included in the catalogue of national essential drugs (2012 version) The consistency evaluation of the chemical generic oral solid preparations approved for marketing before the end of 2018 shall be completed For other generic drugs approved for listing before the implementation of the new registration and classification of chemical drugs, the consistency evaluation shall be completed within 3 years in principle for the same varieties of other drug manufacturing enterprises after the first varieties pass the consistency evaluation, and those that are not completed within the time limit shall not be registered again 　　 Zhejiang Jingxin Pharmaceutical Co., Ltd (hereinafter referred to as "Jingxin pharmaceutical") is a listed pharmaceutical company integrating R & D, production and sales It is a national key high-tech enterprise It has a national enterprise technology center, postdoctoral research station, Zhejiang Enterprise Research Institute and academician expert workstation, and has long been working with many national pharmaceutical research institutions and famous University cooperation, with strong scientific research and technical force, the company adheres to the quality concept of "Beijing new drug, meticulously made", has fully passed the new GMP certification, and the solid preparation production line rate passed the German GMP certification in 2006 In this consistency evaluation, Jingxin Pharmaceutical Co., Ltd ranks among the top pharmaceutical enterprises in Zhejiang Province in terms of variety, specification and quantity There are 17 varieties and 22 approval numbers listed in the national basic drug catalogue (2012 version), and 30 varieties and 45 approval numbers of other oral solid generic drugs Whether it is the transformation and upgrading of APIs to preparations or the internationalization of preparations, Beijing new pharmaceutical industry is one step ahead in awareness and action, and it has also tasted the sweetness of ten years' hard work As the main designer and witness of these key transformations, Jin Zhiping, President of Beijing New Pharmaceutical Research Institute, believes that consistency evaluation is a challenge and an opportunity By accurately selecting appropriate evaluation varieties, conducting tests as early as possible, and systematically controlling risks, we can get the first chance in the competition, or even "overtake in a corner", further enhancing our ability to participate in international competition Power Different from the long-term wait-and-see situation of most enterprises, Beijing New Pharmaceutical Co., Ltd set up a consistency evaluation research center and a full-time QA department at the end of last year, with the deputy general manager of the company personally in charge, giving priority to the evaluation of key varieties The company divides the whole work into reference preparation filing and purchasing, pharmaceutical research, stability test, be filing and research, filing and reporting of application data, etc the estimated time is 16-24 months According to the scientific decision-making schedule, we have formulated a detailed development plan for key varieties, established a linkage mechanism for R & D, production and marketing departments, focused on promotion, and ensured the completion by 2018 Although there are many legal and practical problems in the consistency evaluation, such as how to select the reference preparation, how to evaluate the modified dosage form, the conditions of be exemption, and the serious shortage of be resources But scientificity is a logical consideration throughout the whole decision-making process Through the integration and utilization of external resources, practical problems can be solved Generally, generic drugs have been studied in foreign countries, which can be promoted by using foreign research resources and results for reference or bridging, selecting the right cro company and pre be at the right time The company also saw that the consistency evaluation policy rose to the national level, and combined with the supply side reform, the impact of the consistency evaluation on the industrial pattern is not only the 289 varieties, but also will have a deeper impact on the ongoing research and development of generic drugs and innovative drugs Only by adopting the global unified standards of safety, effectiveness, science and compliance in drug evaluation, strengthening the system construction, actively responding to the situation, and taking the opportunity of consistency evaluation, carrying out the "secondary development" for the varieties under production and research, can the company achieve the second leap forward.