韩国生物类似药注册管理法规体系概况

随着生物技术产业的发展,韩国开始把重点放在提升生物医药制造和临床标准上,逐步从生产仿制药转变为开发更多新分子实体、生物制品和生物类似药。2009年韩国发布了《生物类似药评估指南》,2010年推行了动态药品生产管理规范(c GMP),目前韩国大多数工厂都通过了美国FDA和欧盟药品局(EMA)检查,韩国公司与跨国生物医药公司的合作也越加紧密。从注册分类、注册程序和技术指南体系方面对韩国生物类似药注册管理法规体系做出框架性梳理。

Overview of Korean biosimilar products registration management system

With the development of biotechnology industry, South Korea has begun to focus on the promotion of biomedical manufacturing and clinical standards, and gradually from the production of generic drugs to the development of more new molecular entities, biological products, and biosimilars. In 2009, South Korea issued the "Guidelines on the Evaluation of Biosimilar Products" and introduced cGMP in 2010. Most factories in South Korea have passed inspections by the FDA and the EMA, and the cooperation between Korean companies and multinational biopharmaceutical companies is more closely. A framework review of the registration classification, registration procedures, and technical guidance system of Korean Biosimilar registration and management system are made in this article.