definiens: means [ * ] 1.21 . means ( a ) an Investigational New Drug Application ( as define d in 21 C.F.R. Part 312 et seq . ) filed with the FDA, ( b ) an application for a Clinical Trial Authorisation pursuant to Directive 2001/20 / EC and the regulations promulgated thereund er for initiating clinical trials in the European Union or ( c ) with respect to Argentina, Australia, Brazil, Cana da, Israel, Japan, Mexico, New Zealand, Norway, Russia, Singapore, Switzerland, Turkey and any other country or regulatory jurisdiction, which at the time in question, is a common site for clinical trials in the cardiovascular indications intended for submission to the FDA or European Medi cines Agency, ( i ) an equivalent of the applications described in subsections ( a ) or ( b ) in such country or regulatory jurisdiction or ( ii ) if there is no equivalent to the applications described in s ubsections ( a ) or ( b ) in such country or regulatory jurisdiction, the enrollment of the first subject i n a human clinical trial