definiens: means any national or supranational Governmental Authority, including the U.S. Foodand Drug Administration ( and any successor entity thereto)17(the ) in the United States, the European Medicines Agency ( and any successor entity thereto ) ( the ) or theEuropean Commission ( and any successor entity thereto ), as applicable, in the EU, and the Ministry of Health, Labour, andWelfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan ( or any successor to either of them ) as thecase may be ( the ) in Japan, the Medicines and Healthcare Products Regulatory Agency ( the ) in theUnited Kingdom, or any health regulatory authority in any country that is a counterpart to the foregoing agencies, including, without limitation, HGRAC, in each case, that holds responsibility for development and commercialization of, and thegranting of Regulatory Approval for, a pharmaceutical product in such country