为妥善处理新旧法规的衔接问题 ,减少因法律法规修订对药品注册管理的影响 ,2 0 0 3年 2月 12日 ,国家药品监督管理局印发《关于〈中华人民共和国药品管理法实施条例〉实施前已批准生产和临床研究的新药的保护期的通知》。通知指出 :( 1)对于2 0 0 2年 9月 15日以前已经获得新 In order to properly handle the convergence of the old and new laws and regulations and reduce the impact of the revision of laws and regulations on the administration of drug registration, on February 12, 2003, the State Drug Administration issued the “Implementation Rules for the Implementation of the Drug Administration Law of the People’s Republic of China Before the approval of the production and clinical research of the new drug’s notice of protection. ” The circular states: (1) Newly acquired prior to September 15, 2002