Regional Differences During the ICH Regulatory Consultation Process Between the EU,US,and Japan

Abstract

With the globalization of the pharmaceutical industry, initiatives like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have emerged to tackle the increasingly complex regulatory environment and challenges. During the development of harmonised guidelines, regional regulatory agencies (European Medicines Agency, US Food and Drug Administration, and Japan’s Ministry of Health, Labour and Welfare) collect comments of all their respective stakeholders through public consultation processes. This process should allow for extensive and comprehensive expert input. However, looking at the ICH public consultation process across regions in past years reveals that there is a different approach ICH regulatory parties use to publish the draft guideline as well as the time frames allotted for review and comment. In this study, we analysed the difference over the past 15 years between the timelines provided during the consultation process by the regulatory agencies of the ICH founding members. We showed that the EMA distributes the ICH draft guideline faster and allows a longer period for consultation compared to the FDA and the Japanese authority.