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回顾了药品发展历史、评价特点及药品管理立法的概况。介绍1985年以来,我国制定《药品管理法》、《新药审批办法》,建立卫生部药品审评委员会及临床药理基地等多项新药管理改革措施,并提出进一步完善新药审批管理的设想。
Reviewed the history of drug development, evaluation characteristics and general situation of drug administration legislation. Introduction Since 1985, China has formulated a series of measures for the management of new drug administration, including the Drug Administration Law, the Measures for the Examination and Approval of New Drugs, the establishment of a drug review committee under the Ministry of Health and its clinical pharmacology base, and proposed the idea of further improving the approval and approval of new drugs.