The Drug evaluation Center of the State Food and Drug Administration supported the development of the Northeast pharmaceutical industry in the first training of drug registration technology successfully concluded in Liaoning

9月4日至6On the same day, the Drug Evaluation Center of the State Food and Drug Administration and the drug administration of Liaoning, Jilin and Heilongjiang provinces jointly sponsored a series of training courses on drug registration technology to support the development of Northeast China's pharmaceutical industry successfully held in Jinzhou。Li Jiangning, Secretary of the Discipline Inspection Committee of the Drug Evaluation Center of the State Food and Drug Administration, Guo Xuefeng, secretary of the Party Group and director of the Provincial Food and Drug Administration, and Liu Kewu, secretary of the Jinzhou Municipal Party Committee attended the opening ceremony and spoke。Xu Donglei, Deputy Director of Jilin Provincial Food and Drug Administration and Wang Xiaogang, Deputy director of Heilongjiang Provincial Food and Drug Administration attended the training activity。From the three northeastern provinces237Domestic drug manufacturers, drug marketing authorization holders and drug supervision, technical review, inspection and testing related units personnel total450Others attend training。

The training focuses on two aspects of drug review business knowledge and technical requirements for drug research and development, and is carried out through teaching guidance, on-site Q&A, exchange and discussion。The drug evaluation Center of the State Food and Drug Administration selected talented forces to form a teaching team，Focus on the common problems of registration and declaration widely concerned by pharmaceutical enterprises and the key contents of drug research and development and review，From the drug research and development and technical review communication procedures, chemical drug acceptance review requirements, chemical drug registration review procedures, chemical drug registration verification start-up principles, chemical drug research and development at different stages of pharmaceutical review basic requirements, chemical drug pharmaceutical change technical requirements, specification writing principles, clinical trial design technical requirements8Give lectures in various aspects。During this period, on-site Q&A was organized2Field, answer the concerns of enterprises12Item;Hold an exchange forum3Field, Jinzhou Aohong Pharmaceutical Co., LTD., Shenyang Xingqi Ophthalmology Co., LTD6The enterprise conducted on-site exchanges on the research and development of innovative varieties of the enterprise。

此次培训是国家药监局药品审评中心全面贯彻习近平总书记关于东北全面振兴的重要讲话和指示批示精神，深入落实国家药监局Related work deployment,Help Northeast China's pharmaceutical industry develop in high qualityAn important measure of。Through training and exchanges, a communication mechanism between drug production and research and development enterprises in Northeast China and the Drug evaluation Center of the State Food and Drug Administration has been established, and a service platform has been built to further stimulate the vitality of research and development and innovation of pharmaceutical enterprises。

　　 During the training session，Li Jiangning, secretary of the Discipline Inspection Committee of the Drug Evaluation Center of the State Food and Drug Administration, conducted field research on Jinzhou Aohong Pharmaceutical Co., Ltd. and Jinzhou Jiutai Pharmaceutical Co., LTD，Listen to the opinions and suggestions of enterprises，The policy and technical guidance on drug research and development are also provided，To enhance the enterprise drug research and development ability，Promoting the innovation and development of enterprises has played a positive role in promoting。