OpportunityTitle: Renewal-Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Clinical Trials Not Allowed
AdditionalInformationOnEligibility: Eligible Organizations International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)  Additional Information on Eligibility:Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Description: 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.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592