Kurihara Chieko, Inoue Tomio
Kaku Igaku. 2015 Nov;52(4):341-52.
To identify regulatory framework for approval of PET drugs in Korea.
Interview and literature survey.
In Korea Good Manufacturing Practice (GMP) regulation specific to radiopharmaceuticals, including PET (Positron Emission Tomography) drugs, under the Pharmaceutical Affairs Act was issued in August 2014, to be enforced on July 1, 2015, and its guidance was issued in December 2014. The new facilities to be established after July 1 of 2015 have to be compatible with this new regulation and already established facilities have two years grace period until June 30 of 2017. During this period, the regulatory authority will inspect all of the production sites which hold or submit approvals of radiopharmaceuticals. As of September 2015 in Korea, there are 7 commercial companies and 15 hospitals and institutes, which have approvals of PET drugs mainly FDG, and these companies and/or hospitals can supply PET drugs outside institutions. In this article we introduce the Korean regulations of development and approval of radiopharmaceuticals.
The Korean regulatory authorization policy for radiopharmaceuticals are to some extent similar to the policy which the U.S. regulators set as the new regulations of PET drug. It is expected that the situations of production sites in Korea are to be improved through actual discussions among regulators and PET community through the process of actual inspection.
确定韩国PET药物批准的监管框架。
访谈和文献调查。
韩国于2014年8月发布了《药品事务法》中针对包括PET（正电子发射断层扫描）药物在内的放射性药物的《药品生产质量管理规范》（GMP）条例，该条例于2015年7月1日起实施，其指南于2014年12月发布。2015年7月1日之后新建的设施必须符合这一新规定，已建成的设施有两年宽限期至2017年6月30日。在此期间，监管机构将检查所有持有或提交放射性药物批准文件的生产场所。截至2015年9月，韩国有7家商业公司以及15家医院和机构获得了PET药物（主要是氟代脱氧葡萄糖）的批准，这些公司和/或医院可以向机构外供应PET药物。在本文中，我们介绍了韩国放射性药物开发和批准的相关规定。
韩国放射性药物的监管授权政策在一定程度上与美国监管机构作为PET药物新规定所制定的政策相似。预计通过监管机构与PET领域在实际检查过程中的实际讨论，韩国生产场所的情况将得到改善。
