State Administration for Market Regulation released "Q&A on Registration of Infant Formula Foods for Special Medical Purposes According to the New National Standard"

On April 24, the State Administration for Market Regulation released the Q&A on the Registration of Special Medical Use Infant Formula Foods According to the New National Standard (referred to as the "Q&A" below). The purpose of the Q&A is to guide enterprises in the re-registration of special medical use infant formula foods after the release of the new national standard, "General Rules for Special Medical Use Infant Formula Foods" (GB 25596-2025) (referred to as the new national standard), to ensure a smooth transition in the market. The Q&A specifies that enterprises can submit product registration (including changes) applications according to the new national standard from the date of its release, and can organize production according to the technical requirements of the new national standard after obtaining registration. From the date of implementation of the new national standard, enterprises should organize production according to the technical requirements of the new national standard, and products produced before can be sold until the expiration date. For special medical use infant formula foods that have already been registered, applicants only need to adjust the formula according to the new national standard, and generally handle it as a change registration. Regarding the submission of application materials, it is clarified that materials that have not changed do not need to be resubmitted. Additionally, requirements for stability studies, on-site inspections, and sampling inspections are also specified. The implementation of these optimization measures not only improves the efficiency and transparency of the registration process but also reduces the burden on enterprises, encouraging more companies to invest in the research and production of special medical use infant formula foods. This article is selected from the "Market Speak" WeChat official account, GMTEight editor: Liu Jiayin.