Foods for Special Medical Purposes (FSMP) Formula Development and Process Validation

According to the Administrative Measures on Foods for Special Medical Purposes Registration and its supporting documents, applicants shall possess proper R&D, production, and testing capabilities appropriate for their products. In addition, they are required to submit comprehensive scientific reports on formula development and process validation when seeking for FSMP registration, which shall include product R&D report, product formula design and its basis, production process materials, product standards and requirements, and documentation proving the R&D, production, and testing capabilities. The reports should elaborate on several key aspects, including product formula composition, product energy and nutritional characteristics, the basis for determining formula design, target population and packaging materials, formula characteristics or nutritional features, research materials on the production process (including process design, process flow, and process validation), description of quality control measures, and materials related to effective cross-contamination prevention.

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 FSMP 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 scientific literature research based on clients’ needs;
• Identify the basis for product formula design and its characteristics;
• Identify the suitable population;
• Determine product packaging materials; and
• Determine product technical standards and requirements

2. Product process research

• Offer recommendations for laboratory-scale trial production and product process validation;
• Assist in determining the process route and parameters for the commercial production line;
• Advise on carrying out three batches of commercial-scale trial production and process validation; and
• Provide guidance for conducting full-item inspections of three batches of commercial-scale trial production samples

3. Provide guidance for conducting stability tests in accordance with FSMP stability tests requirements, including accelerated tests, long-term tests and influencing factor testing;

4. Assist in preparing documentation and conducting self-inspection before the on-site inspection in accordance with the key points and principles for on-site inspection of FSMP producers; and

5. Other customized R&D services.