近日，市场监管总局发布《特殊医学用途全营养配方食品注册指南》（以下简称《指南》），进一步落实新修订的《特殊医学用途配方食品注册管理办法》，持续优化完善特殊医学用途配方食品注册管理。《指南》严格依据《特殊医学用途配方食品注册管理办法》，总结梳理特殊医学用途全营养配方食品（以下简称全营养配方食品）的科学认知、注册实践、产品研发及生产实际等内容，从产品配方及其设计依据材料、生产工艺材料、稳定性研究材料、研发能力和生产能力材料、产品标签说明书样稿要求以及现场核查和抽样检验的情形6方面进行优化。对符合《指南》相关要求的，不再要求重复提交产品配方、生产工艺等相关材料，对已获得全营养配方食品注册的企业，不再重复进行现场核查和抽样检验。这些优化措施有利于提升全营养配方食品审评审批效能，降低企业研发注册成本，进一步激发特医食品市场活力。据了解，市场监管总局此前已发布过电解质配方、碳水化合物组件、蛋白质组件等3类特医食品注册指南。
Brief
"On January 14, 2025, the State Administration for Market Regulation issued an update regarding the release of Registration Guidelines for Nutritionally Complete Foods for Special Medical Purposes. This guidelines further implement the revised Regulations on the Registration Management of Dietary Foods for Special Medical Purposes and optimize special medical purpose nutritional foods registration management."
Highlights content goes here...
Purpose:
The release of the “Special Medical Use Full Nutrition Formulation Food Registration Guide” by the Market Supervision Administration aims to further implement the revised “Registration Management Method for Special Medical Use Formulated Foods”, optimizing and perfecting the registration management system for special medical use formulated foods. This guide is a comprehensive document that summarizes scientific knowledge, registration practices, product research and development, and production actuality, among other aspects.
Effects on Industry:
The optimized measures in the guide will significantly improve the efficiency of full nutrition formulation food registration evaluation and approval, reducing the costs for enterprises to develop and register their products. This is a positive step that will stimulate the vitality of the special medical food market. By streamlining the registration process and eliminating redundant requirements, such as submitting product formulations and production processes, the guide aims to reduce the administrative burden on companies. Moreover, the exemption from repeated on-site checks and sampling inspections for registered enterprises will also save them time and resources.
Relevant Stakeholders:
The stakeholders affected by this update are primarily businesses engaged in the research, development, and registration of special medical use full nutrition formulation foods. This includes food manufacturers, researchers, and regulatory bodies responsible for overseeing the industry. The guide is particularly relevant to enterprises that have already obtained registration for their products, as they will no longer need to undergo repeated on-site checks and sampling inspections.
Next Steps:
Companies operating in the special medical use formulated foods sector must familiarize themselves with the revised guide to ensure compliance with the updated regulations. This involves reviewing and adjusting product development, registration processes, and production practices to meet the requirements outlined in the guide. As a result, businesses should:
- Review their existing product formulations, production processes, and research capabilities to ensure they meet the new standards.
- Update their product labels and packaging to conform to the specified guidelines.
- Prepare for potential on-site checks and sampling inspections by regulatory authorities.
- Consider investing in quality control measures and personnel training to maintain compliance with the revised regulations.
Any Other Relevant Information:
The Market Supervision Administration has previously released registration guides for three classes of special medical foods: electrolyte formulations, carbohydrate components, and protein components. These guides have contributed to the optimization of the registration management system for special medical use formulated foods. The release of this latest guide is a continuation of efforts to refine and perfect the regulatory framework for this sector. As the industry continues to evolve, it is likely that further updates and refinements will be made to ensure the continued safety and quality of special medical use full nutrition formulation foods available in the market.
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