Global Food Compliance
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Guidance for the Registration of Nutritionally Complete Food for Special Medical Purposes

Local Title
特殊医学用途全营养配方食品注册指南
Country/Region
Chinese Mainland
Competent Authority
State Administration for Market Regulation
Type
Guideline
Status
In force
Release Date
2025-01-14
Implementation Date
2025-01-14

This is a guidance for the registration of nutritionally complete food for special medical purposes. It clarifies the requirements for formula design and labeling, and simplifies the application materials for product registration as well as the onsite inspection requirements for nutritionally complete FSMP.

Contents

1. Product Formula and Its Design Basis

2. Materials for Production Process Design

3. Materials for Stability Studies

4. Documents on R&D and Manufacturing Capabilities

5. Sample Drafts of Product Labels and Instructions

6. On-site Inspection of the Production Facility

Read more at ChemLinked News: China Issues Guidance for the Registration of Nutritionally Complete Food for Special Medical Purposes (FSMP).

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