definiens: means a human clinical trial of apharmaceutical or biological product : ( a ) with a defined dose or a set of defined dosesof such product designed to establish statistically significant efficacy and safety ofsuch product for the purpose of enabling the preparation and submission of a MAA tothe competent Regulatory Authorities in a country ; ( b ) that would otherwise satisfyrequirements of 21 CFR 312.21(c ), or its equivalent in jurisdictions outside of theUnited States ; or ( c ) that is intended to establish that such product is safe andefficacious for its intended use, and to determine warnings, precautions, and adversereactions that are associated with such product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for a first RegulatoryApproval ( conditional or otherwise ), as evidenced by ( i ) an agreement with orstatement from the applicable Regulatory Authority on a Special Protocol Assessmentor equivalent, or ( ii ) other guidance or minutes issued by the applicable RegulatoryAuthority, for such registration trial