新药审批是药品监督管理工作的一项重要内容,严格把好新药审批这一关,将对新药投产后各个环节的监督管理打下良好的基础,是保证药品安全有效的一个十分重要的措施。《药品管理法》颁布后,卫生部为统一审批全国的新药做了大量准备工作:1985年7月1日颁发 Approval of new drugs is an important aspect of drug supervision and management. Strictly examining and approving new drugs will lay a good foundation for the supervision and management of all aspects of the new drugs after they are put into production, and is a very important measure to ensure drug safety and effectiveness. After the promulgation of the Drug Administration Law, the Ministry of Health has made a large amount of preparatory work for the uniform examination and approval of new drugs across the country: issued on July 1, 1985