This is a guidance for the registration of FSMP for Amino Acid Metabolism Disorders. It clarifies the requirements for formula design, product label, instructions and onsite inspection. It also explains needed materials for the design of production processing, stability research, R&D capacity and production capacity.

Contents

1. Product Formulation and Its Design Basis

2. Materials for Production Process Design

3. Materials for Stability Studies

4. Materials on R&D and Production Capabilities

5. Sample Drafts of Product Labels and Instructions for Use

6. On-site Production Inspection

Read more at ChemLinked News: Guidance for the Registration of FSMP for Amino Acid Metabolism Disorders