On January 14, the State Administration for Market Regulation (SAMR) announced the release of the Guidelines for the Registration of Special Medical Purpose Complete Nutrition Formula Foods, aiming to further implement the newly revised Regulations on the Registration and Management of Special Medical Purpose Formula Foods and continuously optimize the registration process.
The Guidelines strictly adhere to the Regulations on the Registration and Management of Special Medical Purpose Formula Foods, summarizing scientific knowledge, registration practices, product development, and production realities related to complete nutrition formula foods (hereinafter referred to as complete nutrition formulas). The optimization focuses on six aspects: product formulation and supporting documentation, production process documentation, stability studies, R&D and production capacity documentation, product labeling requirements, and on-site inspections and sampling tests.
For applications meeting the relevant Guidelines requirements, there will no longer be a need to resubmit formulation and production process documents. Additionally, enterprises that have already obtained registration for complete nutrition formulas will not be subject to repeated on-site inspections and sampling tests. These measures are expected to enhance the efficiency of evaluations and approvals, reduce R&D registration costs for enterprises, and further stimulate the medical food market. (Source: SAMR)
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