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《新药审批办法》颁布施行已经两年了。两年来,我们除对新药中药申报资料进行审评外,还接待了来自全国各地的来访者和来信。我们就《新药审批办法》的要求等有关技术问题提供了咨询服务。同时,也了解了一些单位开发研制中药新药的动向。根据反映的情况来看,目前大家对《新药审批办法》的条文已有了初步的了解,但是,非常有必要及时分析一下,当前在中药新药开发中广泛存在的隶属科技范围的共性问题,以便帮助科研生产单位在我国新药开发中,控制方向,掌握主动。为此,
The “Approval Measures for New Drugs” has been promulgated and implemented for two years. In the past two years, apart from reviewing new drug application materials for Chinese medicine, we also received visitors and letters from all over the country. We provided consulting services on relevant technical issues such as the requirements for the “Approval Methods for New Drugs”. At the same time, they also learned about the development of new medicines by Chinese companies. According to the situation reflected, at present, everyone has already had a preliminary understanding of the provisions of the “Approval Methods for New Drugs”. However, it is very necessary to analyze in a timely manner the common problems of the scope of science and technology that are widely existing in the development of new drugs in traditional Chinese medicine so that Help scientific research and production units to control their direction and take the initiative in the development of new drugs in China. to this end,