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特殊医学用途婴儿配方食品新国标
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市场监管总局启动特医婴儿配方食品按新国标注册工作
news flash· 2025-04-24 01:04
Core Viewpoint - The new national standard for special medical purpose infant formula food has been officially released and will be implemented on March 16, 2027, aiming to enhance production efficiency and transparency for companies in this sector [1] Summary by Relevant Sections New Standard Implementation - Companies can start applying for product registration according to the new standard from the date of its release, and production can commence once registration is obtained [1] - The new standard requires companies to organize production based on the registered technical requirements starting from the implementation date [1] Registration Process - Existing products can be sold until their shelf life expires, even if they do not comply with the new standard [1] - For products already registered, adjustments to formulas can be processed as change registrations without the need to resubmit unchanged materials [1] Research and Production Oversight - Stability research materials are not required to be submitted, but companies must conduct and retain records of such studies [1] - The registration review agency will organize production site inspections based on risk, and for products that meet certain conditions, on-site inspections and sampling may not be required [1] Industry Impact - The optimization measures are designed to improve the efficiency and transparency of the registration process, reducing the burden on companies [1] - These changes are expected to encourage more companies to invest in the research and production of special medical purpose infant formula food [1] Product Definition - Special medical purpose infant formula food is specifically formulated to meet the unique nutritional needs of infants (0-12 months) with feeding restrictions, digestive absorption issues, metabolic disorders, or specific medical conditions [1] - Such products should be consumed under the guidance of a doctor or clinical nutritionist, either alone or in combination with other foods [1]