中国加入ICH为全球新药申报与临床研发带来的机遇与挑战

Opportunities and Challenges for Global New Drug Submission and Clinical Development after China’s Accession to ICH

中国于2017年加入人用药品技术要求国际协调理事会(ICH)。ICH是制药领域全球最具影响力的非政府组织。中国加入ICH给中国的制药产业带来了巨大的机遇和挑战。从法规监管方面比较了中国与美、欧、日等ICH代表性国家及地区在上市申请、临床申请、沟通交流方面的异同。另一方面,也比较了中国与这些ICH主流国家及地区在临床试验启动效率、临床开发环境以及创新临床研究方法方面的差距,并总结了一些经验教训,供医药企业借鉴。

In 2017, China joined the the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH), which is the most influential non-governmental organization in the pharmaceutical field. This will bring great opportunities & challenges to China’s pharmaceutical industry. From regulatory perspective, this article compares the market authorization, clinical trial application, consultation and communication between China & the ICH members such as the U.S., EU and Japan. Besides, it summarizes the gaps between China and these countries/area in clinical development environments, including clinical start-up, clinical trial environments and innovative clinical trials, with some good experience of reference for the China’s pharmaceutical companies.