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第一条 为加强对药品研究的监督管理,保证药品研究实验记录真实、规范、完整,提高药品研究的质量,根据《中华人民共和国药品管理法》、《国家档案法》以及药品申报和审批中的有关要求,制定本规定。 第二条 凡在我国为申请药品临床研究或生产上市而从事药品研究的机构,均应遵循本规定。 第三条 药品研究实验记录是指在药品研究过程中,应用实验、观察、调查或资料分析等方法,根据实际情况直接记录或统计形成的各种数据、文字、图表、声像等原始资
Article 1 In order to strengthen the supervision and administration of pharmaceutical research and ensure that the experimental records of pharmaceutical research are true, standardized and complete and the quality of pharmaceutical research is improved, according to the “Drug Administration Law of the People’s Republic of China”, the “National Archives Law” and the declaration and approval of drugs The relevant requirements, the enactment of this provision. Article 2 Where in our country to apply for clinical research or drug production and marketing institutions engaged in pharmaceutical research, should comply with these provisions. Article 3 The record of drug research experiment refers to the original data of all kinds of data, characters, diagrams, audio and video, etc. formed by direct recording or statistics according to the actual situation during the process of drug research by means of experiment, observation, investigation or data analysis