In Europe since May 2004, all clinical trials in the 25 nations of the EU must conform to the European Directive (ED) issued in 2001 at the behest of pharmaceutical industry. Each country’s regulatory body will have to issue their own regulations that are within the bound the Directive.
这只是一个事例。全球范围内对人体对象的保护系统要么不存在，要么残缺不全。2004年5月以来，欧盟25个成员国内所有的临床试验都必须遵守根据药品产业界的要求于2001年发布的欧盟指令。每个国家的监管机关都必须根据这一欧盟指令颁布各自的法规。