Education:
1981-1985 B.M. Department of Pharmacy, Xi’an Medical University
2004-2005 MPH. School of Public Health, Harvard University
Professional Positions:
2011-2013 Drug Inspector General, State Food and Drug Administration, Beijing, China
2014-2017 Director General, Center for Medical Device Evaluation, China Food and Drug Administration, Beijing, China
2017-2018 Director General, Department of Medical Device Supervision China Food and Drug Administration, Beijing, China
2018-2023 Director General, Center for Drug Evaluation, National Medical Product Administration, Beijing, China
2023-now Professor, School of Medicine, Tsinghua University, Beijing, China
2024-now Deputy Dean, Institute of Pharmaceutical Regulatory Science, Tsinghua University, Beijing, China
Research Areas:
Pharmaceutical regulatory science. With the rapid development of medical technology, new technologies, materials, and mechanisms are continuously being applied in the medical field, leading to a surge in innovative drug development. Strengthening the regulation of drug research, production, and use is essential to ensure the safety, efficacy, and quality control of drugs. This requires research into new tools, standards, and methods for regulatory science. The research outcomes of pharmaceutical regulatory science can provide scientific evidence and decision support for drug regulatory authorities, offer reference for the formulation of national regulatory policies and regulations, promote the scientific, standardized, and professionalization of drug regulation, and protect the safety, efficacy, and accessibility of medications for the public.
Honors and Awards:
Has been engaged in the regulation of pharmaceuticals and medical devices for a long time, is well-versed in the historical transformation of China’s drug regulatory development, and has presided over multiple research projects on drug and medical device review systems and regulatory science. Participated in the drafting of multiple laws and regulations for drugs and medical devices, actively promoting the reform of China’s drug and medical device review and approval system to improve review efficiency and quality. In recent years, has led several major reforms in the field of new drug research and development review,
Selected Publications:
1. 孔繁圃等 药品研究与评价技术指导原则 2022年 中国医药科技出版社
2. 孔繁圃等 药品研究与评价技术指导原则 2021年 中国医药科技出版社
3. 孔繁圃等 药品研究与评价技术指导原则 2020年 中国医药科技出版社
4. 孔繁圃等 药品审评科学管理手册 （上、下册） 中国医药科技出版社
5. 孔繁圃. 保障患者用药安全有效可及 [N].人民日报,2023-3-20(09).
6. 孔繁圃. 以流程导向科学管理体系建设为抓手深化改革改善研发创新环境 [J].中国新药杂志,2022, (24).
7. 孔繁圃. 持续深化药品审评审批制度改革以优异成绩迎接党的二十大胜利召开 [J].中国新药杂志,2022,v.31(18):1761-1766.
8. 孔繁圃. 深化审评审批制度改革推动药品高质量发展 [J].中国食品药品监管,2022,No.217(02):14-23.
9. 孔繁圃. 坚定不移推动药品审评审批制度改革 [N].中国医药报,2020-12-2(001).
10. 孔繁圃. 尊崇科学精神人民生命至上 [N].中国医药报,2020-11-11(001).
11. 孔繁圃. 医疗器械审评权不能太集中 [N].人民日报,2017-4-13(013).
12. 孔繁圃. 深化改革创新发展提升医疗器械审评科学化水平 [J]. 中国食品药品监,2017,No.159(04):18-20.
