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1985年11月1日起,卫生部根据《药品管理法》的有关规定,开始对全国新药实行统一审批.三年来,通过各方面的努力及有关单位的支持,中药新药的审批工作初步走上了规范化的轨道,新药审批工作的关系基本理顺,在技术方面,各级新药审评委员会专家从技术咨询、临床基地及药检部门的技术指导等方面都发挥了积极、有效的作用.中药新药的开发研制不但数量上有了明显的增加,而且质量上也有了显著提高,特别是对紧缺名贵中药材的开发取得了很大进展.
From November 1, 1985, the Ministry of Health began to implement unified examination and approval of new drugs throughout the country in accordance with the relevant provisions of the “Drug Administration Law.” Over the past three years, through the efforts of various parties and the support of relevant units, the examination and approval of new Chinese medicines has begun. With regard to the standardized track, the relationship between the approval of new drugs has been basically streamlined. In terms of technology, experts at all levels of the New Drug Evaluation Committee have played an active and effective role in technical guidance, clinical bases, and technical guidance of drug testing departments. The development of the research not only has a significant increase in the number, but also has significantly improved the quality, especially the development of the scarcity of valuable Chinese herbal medicines has made great progress.