论文部分内容阅读
新药审批是药政管理的重要一环,是药品标准、药品监督以及药品从生产到使用全过程中保证药品质量的基础,体现着我国药品发展的水平。《药品管理法》明确规定:“国家鼓励研究、创制新药”,“生产新药,必须经国务院卫生行政部门批准。并发给批准文号”。新药由卫生部统一审批管理,是我国药品监督管理上的一大改革,体现了我国政府对新药质量的重视和对人民健康的关怀。
The approval of new drugs is an important part of the administration of medicine. It is the basis of drug standards, drug supervision and drug quality assurance in the entire process from production to use, which reflects the level of drug development in China. The Drug Administration Law stipulates that “the state encourages research and creation of new drugs” and that “the production of new drugs must be approved by the health administrative department of the State Council and issued with the approval number.” The approval of new drugs by the Ministry of Health, a unified review and approval, is a major reform of China’s drug regulatory administration, reflecting the importance of our government on the quality of new drugs and people’s health concerns.