This guideline specifies the application materials, items, and detailed requirements for the formula registration of liquid infant formula products in China. It applies to both domestically produced and imported products intended for infants (0-6 months), older infants (6-12 months), and young children (12-36 months). The document outlines general requirements for the submission format and details the specific content required for nine categories of application materials, covering aspects from applicant qualification and formula rationale to production process validation and product testing. It also includes templates for application forms and a technical guideline for conducting shelf-life stability studies.

Contents

1. General Requirements for Application Materials

2. Items and Requirements for Product Formula Registration Application Materials

Attachment 1: Application Form for Formula Registration of Domestic Liquid Infant Formula Products

Attachment 2: Application Form for Formula Registration of Imported Liquid Infant Formula Products

Attachment 3: Guideline for Shelf-life Stability Study of Liquid Infant Formula Products