China SAMR Clarifies FSMP Registration Requirements Under New GB Standards

On March 18, 2026, China's State Administration for Market Regulation (SAMR) released a Q&A document to guide the registration of Foods for Special Medical Purposes (FSMP) under the new national standards (GBs). The document clarifies the transition timeline, application procedures, dossier requirements, and specific rules for different product categories, including when new clinical trials are necessary.

The Q&A addresses the implementation of new standards such as the GB 29922-2025 General Standard for Foods for Special Medical Purposes. From the date the new standards are released, applicants can submit registration or change applications in compliance with them. However, starting from the official implementation date of the new standards, all production must adhere to the new requirements. Products manufactured under the previous standard (GB 29922-2013) can be sold until their shelf life expires.

The Q&A document answers the following ten questions. The full text is translated below for reference only.