Abstract
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.
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