As stipulated in the Administrative Measures for Health Food Registration and Filing and its supporting documents, applicants are required to submit a comprehensive research report when seeking for health food registration, which shall include 4 key components, namely a safety evaluation report, a health function evaluation report, a manufacturing process research report, and a study on product technical requirements. The report should elaborate on several key aspects, including the safety and effectiveness basis for product formulation compatibility and use levels; the basis for selecting excipients and dosage forms; the process from small-scale study to scale-up validation and process optimization; and the rationale behind establishing product technical specifications, including each parameter and the respective analytical methods. Therefore, gathering valid research data and scientific justifications throughout the R&D process is crucial for securing regulatory approval and ensuring a successful product launch in the market.
With over a decade of expertise in health food application, CIRS Group has established long-term partnerships with several renowned research institutions with extensive R&D experience. Our team is well-equipped to offer tailored formula design, process research, and data collection services based on clients’ needs and product registration requirements. This ensures scientifically sound support for future product registration applications and commercial production.
Product R&D Service
1) Product formula research:
- Conduct tailored scientific literature research;
- Determine product formula and composition basis;
2) Product process research:
- Conduct research on the manufacturing process of raw materials and establish quality standards;
- Conduct research on the product forming process, including the selection of excipients and specifications determination;
3) Establish product technical requirements, identify characteristic components, and carry out methodological validation;
4) Provide small-scale process research materials and literature research reports;
5) If needed, assist in contacting the sample production unit and guide the company to conduct three-batch pilot production;
6) If needed, conduct validation of the product function in advance in accordance with the health food functional evaluation methods;
7) If needed, coordinate with the review agency for on-site inspection and provide relevant materials; and
8) Other customized R&D services.
Our Services
- SAMR Health Food (Dietary Supplement) Registration/Filing in China
- China Health Food Testing Service
- Change of Health Food Registration Certificate Service in China
Other Services
- NHC New Food Raw Material Registration in China
- NHC New Food Additive Registration in China
- Genetically Modified Microorganism Food Additive Registration in China
- SAMR Food for Special Medical Purpose (FSMP) Registration
Further Information
