摘要
目的通过对再注册申报资料进行审查分析,从技术角度阐述医疗机构制剂在药学方面存在的问题,以促进其向更规范的方向发展。方法对医疗机构制剂再注册审评工作进行梳理、总结和规纳。结果与结论医疗机构制剂在各方面仍有提高的空间,应促进其逐步完善。
Objective To expatiate the problems of preparations developed by medical institutions in pharmacological aspect through review and analysis of re-registration data, so as to advance the development of preparations by medical institutions. Methods The problems found during the review of the re-registration data of preparations developed by medical institutions were summed up. Results and Conclusion There is still large room for improvement of preparations developed by medical institutions in all aspects, and it should be improved in a gradual way.
出处
《中国药事》
CAS
2014年第2期147-150,共4页
Chinese Pharmaceutical Affairs
关键词
医疗机构制剂
再注册
preparations developed by medical institutions
re-registration
