创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

2020年江苏省药品注册分析报告

2020 Annual Report on Drug Registration in Jiangsu Province

  • 摘要: 2020年江苏省药品注册批准上市品种以及创新药数量保持全国第1,仿制药质量和疗效一致性评价工作走在全国前列。为保证疫情防控期间药品注册审评审批正常进行,江苏省药品监督管理局积极与国家药品监督管理局食品药品审核查验中心联合开展药品注册核查工作,承接任务占全国的1/4以上。按时完成药品再注册,全省常年生产品种占42.6%。稳步推进“放管服”改革,不断深化审评审批制度改革,持续优化营商环境。

     

    Abstract: In 2020, the number of registered and approved drug varieties and innovative drugs in Jiangsu province ranked the first in China, and the quality and efficacy consistency evaluation of generic drugs was also leading in the country. In order to ensure the normal process of drug registration and approval during the prevention and control of COVID-19, Jiangsu Medical Products Administration actively cooperated with the Center for Food and Drug Inspection of the National Medical Products Administration for drug registration verification of more than one-fourth of the total amount of work in the country, with drug re-registration work being completed on time and the annual number of drug varieties produced in Jiangsu province accounting for 42.6%. We will continue to promote the reform of "streamlining administration, delegating power, strengthening regulation, and improving services", further deepen the reform of the review and approval system, and continuously optimize the business environment in the province.

     

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