This document provides official answers to frequently asked questions regarding the registration of Foods for Special Medical Purposes (FSMP) in accordance with China's new national standard (e.g., GB 29922-2025, GB 31662-2025). It clarifies the transition timeline, procedures for registration changes versus new applications, dossier requirements, and specific technical requirements for different types of FSMP, such as partially modified nutritionally complete formulas and formulas for specific diseases.

Contents

1. When Can Applicants Submit Registration Applications According To The New National Standards? When Must Production Be Organized According To The New National Standards?

2. When Applying For Registration Under The New National Standards, Which Situations Are Handled As Changes And Which As New Product Registrations?

3. For Products Already Registered, What Application Materials Are Required For Registration (Including Changes) Under The New National Standards? Are Stability Study Materials, On-site Inspections, And Sampling Tests Required?

4. Which Products Can Apply For A Change In Product Category According To The New National Standards?

5. What Materials Should Be Provided For Partially Modified Nutritionally Complete Foods Regarding Their Product Formula Design And Applicable Population With Special Medical Conditions?

6. Can The "Registration Guideline For Nutritionally Complete Foods For Special Medical Purposes" Be Applied To Partially Modified Nutritionally Complete Foods?

7. What Materials Regarding The Applicable Population With Special Medical Conditions Should Be Provided For Deeply Hydrolyzed Protein Formulas For Children Aged 1-10 Years?

8. Which Categories Of Products Under The New National Standards Require Clinical Trials?

9. What Are The Registration Requirements For Nutritionally Complete Foods For Oncology?

10. What Conditions Must The Application Materials For Products Registered Under The New National Standards Meet?