definiens: means all laws, statutes, rules, regulations ( including, without limitation, current Good ManufacturingPractice Regulations as specified in 21 C.F.R. ( S)(S ) 210 and 211 ; Investigational New Drug Application regulations at 21C.F.R. ( S ) 312 ; World Health Organization Good Manufacturing Practices, the European Union Guide to Good ManufacturingPractice for Medicinal Products, the body of European Union legislation in the pharmaceutical sector as is compiled inVolume 1 and Volume 5 of the publication includingEuropean Union Directive 2001/83 / EC, applicable ICH Guidelines ; NDA regulations at 21 C.F.R. ( S ) 314, relevant provisionsof the Federal Food, Drug and Cosmetic Act and other laws and regulations enforced by the FDA, and ordinances and otherpronouncements having the binding effect of law of any Governmental Authority