传统药物监管科学国际共享的重要实践  

Important practice of international sharing of traditional medicine regulatory science

作　　者：吴函蓉 李菲菲 雷海民[2,3] 耿红冉 费文婷[2] 徐新房 范玲 徐安龙 WU Han-rong;LI Fei-fei;LEI Hai-min;CENG Hong-ran;FEI Wen-ting;XU Xin-fang;FAN Ling;XU An-long(China National Center for Biotechnology Development,BEIJING 100039,China;Beijing University of Chinese Medicine,BEIJING 100102,China;Institute of Regulatory Science for Traditional Chinese Medicine,National Medical Products Administration,BEIJING 100102,China;NMPA Key Laboratory for Research and Evaluation of Traditional Chinese Medicine,BEIJING 100102,China)

机构地区：[1]中国生物技术发展中心,北京100039 [2]北京中医药大学,北京100102 [3]国家药品监督管理局中药监管科学研究院,北京100102 [4]国家药品监督管理局中医药研究与评价重点实验室,北京100102

出　　处：《中国新药与临床杂志》2024年第4期257-262,共6页Chinese Journal of New Drugs and Clinical Remedies

基　　金：中国APEC合作基金项目。

摘　　要：随着我国药品监管国际化水平的显著提升,中药监管已经进入全球化监管协调的新阶段,中药监管科学作为监管科学在中药监管领域应用的新兴前沿学科,在我国迅速发展。本文详细介绍了我国及世界主要发达国家和地区传统药物监管科学的发展现状,并对国内外传统药物国际平台建设和合作情况进行了细致梳理,重点介绍了我国在传统药物监管科学国际共享方面的实践,指出在国际竞争新形势下积极搭建国际传统药物监管科学的科技创新交流合作平台,可以填补该领域国际平台建设空白,推动开展传统药物监管科学领域的实质性合作。With the significant improvement of the internationalization level of drug supervision in China has been significantly improved,and the regulation of TCM has entered a new stage of global TCM regulatory coordination.Meanwhile,TCM regulatory science is an emerging frontier discipline in the application of TCM supervision and developing rapidly in recent years.This paper introduced in detail the development status of traditional medicine regulatory science in China and the world's major developed countries and regions,and carefully sorted out the construction and cooperation of international platforms for traditional medicine at home and abroad,focusing on China's practice in international sharing of traditional medicine regulatory science.Actively building an international platform for scientific and technological innovation exchanges and cooperation in traditional drug regulatory science under the new situation of international competition can fill the gaps in the construction of international platforms in this field and promote the development of substantive cooperation in the field of traditional drug regulatory science.

关 键 词：中医药管理 组织与合作 国际合作 传统药物 监管科学 科技创新 亚洲太平洋经济合作组织 

分 类 号：R95[医药卫生—药学]