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中华人民共和国药品管理法已于一九八五年七月一日起施行。《药品法》第二十一条规定:“研制新药,必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品,经批准后,方可进行临床试验或者临床验证”。如何进行药理、毒理以及临床试验(验证)呢?王少坤等同志根据瑞典国家卫生福利事业部“药品注册”一书,摘译了有关部分,介绍瑞典政府对新药研究的一些具体要求,供读者参考。
The People’s Republic of China Drug Administration Law came into effect on July 1, 1985. Article 21 of the Drug Law stipulates: “For the development of new drugs, relevant materials such as research methods, quality indicators, pharmacological and toxicological test results, etc. shall be submitted to the administrative department of health under the State Council or the administrative department of health under the State Council in accordance with the provisions and Samples, after approval, before clinical trials or clinical validation. ” How to carry out pharmacology, toxicology and clinical trials (verification)? Wang Shao-kun and other comrades according to the Swedish National Health and Welfare Division, “Drug Registration,” a book, translated the relevant section, describes the Swedish government on the new drug research for some specific requirements for readers reference.