1. The trial guidelines for infant formula registration have been finalized and detail the requirements and practical elements involved in compiling infant formula registration dossiers. Overall the trial versions have optimized certain procedures and removed some unpractical requirements when compared to the draft version. 2. Outlining the requirements for expounding the scientific rationale for formula development is the major focus. Scientific information relating to formula comparability with natural breast milk or other supporting nutritional research can be used to meet this requirement.
On Nov. 16, 2016, China CFDA released the finalized version of two supplementary documents for infant formula recipe registration which will serve as a practical guidance for the implementation of “Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes” released by CFDA on 8 Jun 2016. These include:
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