龙年新春伊始,我刊就医药界非常关注的药品注册的有关政策、法规和程序采访了药品注册司司长张世臣教授。案头摆放着许多待批文案的张司长,带着专家学者的儒雅,在百忙中挤出时间,对我刊的一些提问娓娓而谈。现摘要如下,以飨读者。 At the beginning of the Year of the Dragon, I published the relevant policies, regulations and procedures on drug registration which are of great concern to the medical community and interviewed Professor Zhang Shichen, director of the Drug Registration Department. Mr. Zhang, the director of many cases waiting for approval, put time on his busy schedule with some refinements from experts and scholars, and gave some explanations to some of my questions. Abstracts are as follows to readers.