What is the status of ICH in U.S.?

Answer 1

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is actively involved in the U.S. regulatory landscape, particularly in harmonizing drug development standards between the U.S., Europe, and Japan. The U.S. Food and Drug Administration (FDA) participates in ICH, contributing to the development and implementation of guidelines that support the efficient and effective regulation of pharmaceuticals. As of now, the ICH continues to influence U.S. drug approval processes by promoting consistency and reducing duplication in clinical trial data requirements. Overall, ICH is regarded as a key player in enhancing global pharmaceutical regulatory practices.