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目的总结并分析2012年北京市医疗机构制剂注册申请概况及申报中应关注的若干问题,旨在提出一些制剂申报过程中应关注的事项,以供制剂注册申请人参考。方法通过对2012年北京市医疗机构制剂的申报情况进行汇总,同时与往年的数据进行比较和分析,针对北京市医疗机构制剂注册申请及申报具体过程中遇到的实际问题,提出制剂申请过程中的注意事项。结果通过对近几年申报的医疗机构制剂注册申请及申报的汇总及分析,发现存在一些不符合国家食品药品监督管理局《医疗机构制剂注册管理办法》(试行)和北京市药品监督管理局制定的《北京市医疗机构制剂注册管理办法实施细则》(试行)中要求的共性问题,需要提请申请人予以关注,以免影响申报进程。这些共性问题主要包括以下几方面:医疗机构化学药品制剂原料药的要求、中药饮片入药检验的要求、中药制剂功能主治书写应规范、制剂规范和包装规格的要求、延长有效期的补充申请的要求和关于医疗机构制剂价格的管理规定等。结论医疗机构制剂是指医疗机构根据本单位的临床需要并经有关部门批准而配制、自用的固定处方制剂,因其应是市场上没有供应的制剂品种,因此该种制剂注册申请及申报中遇到的问题更应该引起申报单位或个人的注意,以免影响其正常注册及申报。
OBJECTIVE To summarize and analyze some issues that should be paid attention to during the application and registration of preparations registration in medical institutions in 2012 in order to put forward some issues that should be paid attention to in the process of declaration of preparations for the reference of applicants for registration of preparations. Methods By summarizing the report of the preparation of medical institutions in Beijing in 2012 and comparing with the data of previous years, aiming at the actual problems encountered in the process of application registration and declaration in Beijing medical institutions, Precautions. Results Through the compilation and analysis of the applications for registration of preparations of medical institutions in recent years and the analysis of their declarations, there were some cases that did not meet the requirements of the Measures for the Administration of Registration of Pharmaceutical Preparations (Trial) of the State Food and Drug Administration and the Beijing Municipal Drug Administration Of the “Beijing Medical Institutions Registration Regulations” (Trial Implementation) requirements of common problems, need to be brought to the attention of applicants, so as not to affect the reporting process. These common issues mainly include the following aspects: the requirements of the pharmaceutical raw materials of medical institutions, the requirements for the testing of Chinese medicinal herbs, the specification of the main indications of Chinese medicinal preparations, the requirements of formulation specifications and packaging specifications, the requirements for extending supplementary medicinal products Medical institutions on the preparation of the price regulations. Conclusion The preparation of medical institutions refers to the fixed prescriptions prepared by medical institutions according to the clinical needs of the unit and approved by the relevant departments and used for personal use because they should not be supplied on the market. Therefore, To the issue should even cause the reporting unit or individual attention, so as not to affect their normal registration and reporting.