On March 18, 2026, China's State Administration for Market Regulation (SAMR) officially released the "Q&A on the Registration of Foods for Special Medical Purposes (FSMP) Under the New National Standards" (????????????????????), guiding enterprises to comply with GB 29922—2025 (General Standard for Foods for Special Medical Purposes) and GB 31662—2025 (Standard for Tumour Complete Nutritional Formula Food), ensuring a smooth and orderly market transition. From the date the new standards are published, applicants may submit registration or variation applications in accordance with them, and once registered, may organize production accordingly. From the official implementation date of the new standards, all production enterprises must organize production in accordance with the new standards. Products previously produced under GB 29922-2013 may be sold until their shelf life expires.
The Q&A also clarifies that for already-registered products where changes involve only formula adjustments, labeling, or product category modifications, applications should in principle be handled as variation registrations. Where changes simultaneously involve production processes or other core content that substantially constitutes a new formula, the original product must be cancelled and a new product registration submitted. This boundary clarification reduces regulatory uncertainty while providing enterprises with a clear path for product portfolio optimization. For products where variation applications are submitted under the new national standard, materials that have not changed do not need to be resubmitted; stability study materials also do not need to be submitted but must be conducted and retained on file for inspection. In terms of on-site production inspections, for products where only technical adjustments have been made under the new standard and no substantial changes to production processes have occurred, on-site inspections and sampling tests are generally no longer required.
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