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Position: Home > Articles > Suggestions for Research and Development on Formula Food for Special Medical Purposes Food and Nutrition in China 2017,23 (04) 8-10

关于特殊医学用途配方食品研发的几点思考

作  者:
王星
单  位:
国家食品药品监督管理总局保健食品审评中心
关键词:
特殊医学用途配方食品;产品研发;注册管理
摘  要:
目的:2015年10月1日,《中华人民共和国食品安全法》正式颁布实施,赋予了特殊医学用途配方食品的法律地位,结合注册审评法规及产品特点,对特殊医学用途配方食品的研发提供参考建议。生产企业应当具备相应的研发机构、设备和人员,注重产品配方、生产工艺和稳定性等研发过程。方法:系统整理相关法律法规对特殊医学用途配方食品研发的要求,结合产业发展现状及特点进行讨论分析。结果:生产企业应具备相应的研发机构、设备和人员,注重产品配方、生产工艺和稳定性等研发过程。结论:生产企业应当注重特殊医学用途配方食品的研发管理并建立第一责任人的理念,注册审评部门应当与时俱进、创新工作方式,共同促进特殊医学用途配方食品产业规范、快速发展。
译  名:
Suggestions for Research and Development on Formula Food for Special Medical Purposes
作  者:
WANG Xing;Center for Health Food Evaluation,China Food and Drug Administration;
关键词:
Formula Food for Special Medical Purposes(FSMP);;product research and development;;registration and administration
摘  要:
【Objective】The Food Safety Law of The People's Republic of China has cleared the legal status of formula food for special medical purposes in China.The paper provided suggestions for research and development on formula food for special medical purposes based on laws,regulations and product features.【Method】Related requirements in laws and regulations for research and development of formula food for special medical purposes were collected and analyzed.【Result】Manufacturers should have the capacity of organization,instruments and personnel for researching and focus on the research and development of formula,production process and stability.【Conclusion】Manufacturers should pay attention to the procedure and management of research and development and take the first responsibility to quality and safety of the products.Administration department should establish appropriate system to evaluate and supervise the products.

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