全国医疗机构制剂注册管理现状研究

Study on Current Status of Registration Management of Pharmaceutical Preparations in Medical Institutions in China

目的:了解医疗机构制剂注册管理现状和存在问题,为药品监管部门制定相关政策提供参考。方法:采取问卷调查、实地调研、文献分析、会议座谈、深度访谈等多种形式进行调查。结果:通过调研获得了全国医疗机构制剂注册信息,了解了各省、自治区、直辖市制剂管理的具体方式,征求了省级药品监管部门、医疗机构以及部分名老中医专家对现行制剂管理模式的意见和建议。结论:现行管理模式基本适合我国医疗机构制剂现状,《医疗机构制剂注册管理办法(试行)》的实施有效遏制了制剂批准文号的盲目增加,推动了制剂注册管理水平的提高,但尚有需要完善改进之处。

Objective： To understand the current situation of registration management of pharmaceutical preparations in medical institutions and the existing problems so as to provide references for the drug supervision and administration department to draft relevant policies. Methods： A variety of investigation forms were adopted, such as questionnaire survey, field investigation, literature analysis, meeting and depth interviews. Results： The information of pharmaceutical preparations registration of medical institutions in China was obtained. The specific management methods in each province, autonomous region and municipality of China were surveyed. The opinions and suggestions on current management mode were collected from the provincial drug supervision and administration departments, medical institutions and famous traditional Chinese medicine doctors. Conclusion： The current management mode is suitable for the current conditions of pharmaceutical preparations in medical institutions in China. The implementation of Provisions for the Registration of Pharmaceutical Preparations in Medical Institutions（interim） effectively slowed down the growth rate of the new approval number, and improved the level of registration management of pharmaceutical preparations, however, the provisions still need to be perfected.