Recently, the State Administration for Market Regulation issued the Guideline for Registration of Electrolyte Formula Food for Special Medical Purpose, the Guideline for Registration of Carbohydrate Component Formula Food for Special Medical Purpose and the Guideline for Registration of Protein Component Formula Food for Special Medical Purpose (hereinafter referred to as the Guidelines), optimizing the registration management requirements of the three types of products, guides enterprises to further implement the main responsibilities of food safety and ensure the nutritional safety of food for special medical purpose.

The Guidelines strictly follow the "four strictest" requirements of food safety, and optimize the application materials for three types of product registration from four aspects based on scientific cognition, registration practice, product R&D and production actual situation. For products that meet the corresponding circumstances of the Guidelines, firstly, in terms of product formula design basis, only the conformity statement of product formula need to be submitted, and the product formula design basis may not be submitted when applying for registration; Secondly, in terms of production process design, only the consistency description of process design, form selection, process, etc. needs to be submitted, and the production process design basis, documentation, etc. may not be submitted when applying for registration; Thirdly, in terms of stability research, on the basis of organizing stability research in accordance with relevant requirements and keeping records for future reference, when applying for registration, only the time of stability research and related information need to be submitted, and research reports may not be submitted; Fourthly, in terms of R&D production capacity, when applying for registration, only a consistency statement on R&D institutions, main facilities and equipment of production sites, production quality management system, etc. need to be submitted, the original documents and certification materials of R&D capacity and production capacity may not be submitted.

The Guidelines also specifies the circumstances under which the registration of the above three types of products requires on-site verification and sampling inspection, including: the applicant applies for registration of food for special medical purpose for the first time; The production line is used for the first time to apply for registration of food for special medical purpose; Other situations requiring on-site verification and sampling inspection, including concealing the true situation or providing false materials in the previous registration application, related reporting problems or the supervision and management department believes that verification is necessary, and on-site confirmation is considered necessary in the process of technical review. In addition to the above circumstances, production site verification and sampling inspection are generally no longer carried out.

The Guidelines are formulated in accordance with the Measures for the Registration Administration of Food for Special Medical Purpose and relevant provisions, which is conducive to reducing the cost of enterprise research and development, shortening the registration time, and better meeting the clinical nutritional needs of patients and promoting the high-quality development of the special medical food industry.

Source: SAMR

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