《特殊医学用途婴儿配方食品按新国标注册问答》发布

Core Points - The State Administration for Market Regulation released a Q&A document regarding the registration of special medical purpose infant formula food under the new national standard [1] - The Q&A aims to facilitate the re-registration process for special medical purpose infant formula food following the release of the new national standard GB 25596-2025 [1] Summary by Sections Registration Process - Companies can submit product registration applications according to the new standard immediately after its release, and production can commence once registration is obtained [1] - From the implementation date of the new standard, companies must organize production according to the technical requirements of the new standard, while previously produced products can be sold until their expiration date [1] Application Materials - For already registered special medical purpose infant formula foods, applicants only need to apply for a change registration when adjusting formulas according to the new standard [1] - It is clarified that unchanged application materials do not need to be resubmitted [1] Research and Inspection Requirements - The document outlines requirements for stability studies, on-site production inspections, and sampling inspections [1] Impact on Industry - The implementation of these optimization measures enhances the efficiency and transparency of the registration process, reduces the burden on companies, and encourages more enterprises to invest in the research and production of special medical purpose infant formula food [1]