Tominaga Toshiyoshi
1 Food and Drug Evaluation Center, Osaka City University Hospital, Osaka, Japan.
Ther Innov Regul Sci. 2013 Sep;47(5):572-580. doi: 10.1177/2168479013494393.
Comparison of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Global Harmonization Task Force (GHTF), the global regulatory harmonization initiatives in the field of drugs and medical devices, respectively, reveals that "harmonization" activities contain several categories. It was also found that the target level of harmonization (ie, that of technical regulatory requirements and that of regulatory processes) greatly affects the implementability of final work products. Those products concerning regulatory processes (most of the GHTF Documents) often require legal changes and are more difficult to implement than those regarding technical requirements (all of the ICH Guidelines), usually implementable by regulatory authorities publishing them as nonbinding suggestions. Globalization of medical product development, manufacture, and distribution increasingly requires regulatory cooperation across borders, which inevitably affects the initiatives. Identifying what "harmonization" each harmonization initiative aims at is indispensable in determining future directions.
分别对人用药品注册技术要求国际协调会议（ICH）和全球协调工作组（GHTF）这两个药品和医疗器械领域的全球监管协调倡议进行比较后发现，“协调”活动包含几个类别。还发现，协调的目标水平（即技术监管要求的目标水平和监管流程的目标水平）对最终工作成果的可实施性有很大影响。那些涉及监管流程的产品（大多数GHTF文件）通常需要法律变更，并且比涉及技术要求的产品（所有ICH指南）更难实施，后者通常可由监管机构作为非约束性建议发布来实施。医疗产品开发、制造和分销的全球化日益需要跨境监管合作，这不可避免地影响到这些倡议。确定每个协调倡议所针对的“协调”内容对于确定未来方向至关重要。
