The second level guiding principles Seminar on ICH pharmacovigilance was successfully held

Source: China Association for the promotion of pharmaceutical innovation, March 19, 2018, the State Food and Drug Administration issued the announcement on the application of the secondary guiding principles of the International Conference for the registration of human drugs (No 10, 2018) (hereinafter referred to as the "announcement") In order to better implement the requirements of the announcement, on March 17, 2018, a seminar on secondary guiding principles related to ICH pharmacovigilance, sponsored by China Pharmaceutical Innovation Promotion Association (hereinafter referred to as "China pharmaceutical promotion association"), was held in Beijing Zhou Siyuan, director of ICH Work Office of State Food and Drug Administration (hereinafter referred to as "the General Administration"), deputy director of drug review center, song Ruilin, executive chairman of China Association for the promotion of drugs, and leaders and staff of drug review center, drug evaluation center, information center and China Pharmaceutical Association of the General Administration attended the meeting The meeting was presided over by Dr Tan Lingshi, chairman of innovation and R & D Service Professional Committee of China pharmaceutical promotion association, and Dr Zhang Dan, vice chairman More than 300 representatives from more than 100 enterprises engaged in pharmacovigilance and innovative drug R & D from China pharmaceutical promotion association and all over the country attended the meeting Director Zhou Siyuan delivered a speech at the seminar, introducing in detail the coordination, system construction, technical preparation and training carried out by the general administration to promote the implementation of ICH related guiding principles in China He said that the implementation of ICH related secondary guiding principles will greatly promote the awareness of drug registration applicants and marketing license holders to bear the main responsibility of drug vigilance and the ability of safety risk control, promote the improvement of China's drug vigilance system and improve the level of public drug safety Zhou Siyuan (left), director of ICH work office and deputy director of drug evaluation center of the General Administration, delivered a speech Wang Tao (middle), director of Clinical Department II of drug evaluation center of the General Administration, and Dong Duo (right), director of chemical and Biological Drug Department of drug evaluation center of the General Administration, made reports Wang Tao, director of Clinical Department II of drug evaluation center of the General Administration, introduced how to implement According to the requirements of relevant secondary guiding principles, for the report of suspected unexpected serious adverse reactions (susar) data during the clinical study of drugs, establish the safety signal analysis standard and logic during the clinical study and the requirements for enterprises to submit susar in the form of e2b It provides a general idea for the analysis and submission of susar data during the period of clinical research Dong duo, director of the chemical and biological medicine department of the drug evaluation center of the General Administration of China, introduced the existing problems of ADR monitoring in China at present According to the requirements of relevant guidelines of ICH and referring to the pharmacovigilance system of foreign countries, in the future, we will strengthen the requirements of ADR report and risk control, establish the information system of ADR direct report and refine the requirements of technical guidelines Dr Anna Zhao, deputy leader of msso expert group of ICH International Dictionary of medical terms (MedDRA), was invited to introduce the development overview, coding rules and subscription usage of ICH MedDRA She said that MedDRA is applicable to individual safety report, clinical research report, researcher's manual, listing application, prescription information and other links in the whole regulatory process from pre listing to post listing, which is conducive to promoting the standardization of drug safety data entry, retrieval, evaluation and presentation, realizing the electronic information exchange between enterprises and regulatory agencies, and promoting the number of drug safety It is important to make the comparison and understanding consistent The meeting also invited Liang Bing, senior director and head of global drug safety monitoring and risk management department of Pfizer China R & D center, Zhu Rong, head of drug safety and pharmacovigilance of TIMA Biomedical Technology Co., Ltd., Meng Yuan, head of China cross business drug safety of Xi'an Janssen Pharmaceutical Co., Ltd., Ma Huan, head of information management team of Pfizer China R & D center, to The establishment of pharmacovigilance system, the quick report of safety data of clinical research related to E2A, M1 and e2b guiding principles, MedDRA data retrieval strategy and SMQ application, the concept and practical operation experience of electronic transmission of individual safety report data, etc have made wonderful and detailed reports Discussion 1 (top, left to right): Tan Lingshi, Zhou Siyuan, Wang Tao, Dong duo, Liang Bing discussion 2 (bottom, left to right): Zhang Dan, Zhu Rong, Meng Yuan, Ma Huan, Tan Lingshi this meeting from ICH From the perspective of concepts and applications of E2A, M1 and e2b, through the interpretation and interaction of leaders of relevant regulatory agencies and experts of enterprises with rich practical experience, this paper comprehensively demonstrates the regulatory requirements, application strategies and enterprise operation practices of implementing relevant secondary guiding principles of ICH in China The meeting promoted the industry's comprehensive understanding of the secondary guiding principles and regulatory ideas of ICH E2A, M1, e2b and laid a foundation for the comprehensive transformation and implementation of the relevant secondary guiding principles of ICH in China In the future, CFDA will actively cooperate with the ICH Work Office of the general administration to do a good job in training the implementation of ICH related guiding principles in China, so as to promote the level of drug research and development and risk management in China in line with the international standards, and enhance the innovation and international competitiveness of Chinese pharmaceutical enterprises.