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为加强药品监督管理,保证药品疗效,保障人民用药安全、有效,《中华人民共和国药品管理法》自1985年7月1日正式施行,这标志着我国药品监督管理工作进入法制化新时期,体现了我国政府对人民健康的重视和关怀。《药品管理法》第二十一条、二十二条对新药审批作了明确规定,改革了药品审批制度,变分散各地审批为集中统一审批;颁布了
In order to strengthen the supervision and management of drugs, ensure the efficacy of drugs, and ensure the safe and effective use of drugs by the people, the “Drug Administration Law of the People’s Republic of China” was formally implemented on July 1, 1985, which signifies that China’s drug supervision and management work has entered a new period of legalization, reflecting The Chinese government attaches great importance to people’s health and care. Article 21 and 22 of the Drug Administration Law clearly stipulate the examination and approval of new drugs, reformed the drug approval system, and changed the examination and approval of all localities into centralized examination and approval;