Renewal-Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Clinical Trials Not Allowed

The Food and Drug Administration announces its intention to consider and accept a renewal application for award to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this program is to provide support in convening regional pharmaceutical regulatory authorities and pharmaceutical industry associations representing regions and jurisdictions from around the world to achieve greater harmonization of scientific and technical standards for pharmaceuticals. This is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner, to be available to patients globally. The outcome of this effort will be a series of internationally recognized guidelines for pharmaceutical product registration, adopted by regulators in regions around the world.