15 April 2016, CFDA issued relevant regulations for“Administrative Measures on Foods for Special Medical Purpose (FSMP) Registration” published on 7 March 2016. The related regulations include“Application Materials and Requirements of Foods for Special Medical Purpose (for comment)”, “Label and Specification Samples of Foods for Special Medical Purpose (for comment)”, “Regulation on Clinical Trail Quality Control of Foods for Special Medical Purpose (for comment)”, “Stability Research Requirement of Foods for Special Medical Purpose (for comment)”, “Spot Inspection Point and Judging Principle for Manufacturer of Foods for Special Medical Purpose(for comment)”.
According to “Application Materials and Requirements of Foods for Special Medical Purpose (for comment)”, FSMP registration requires the following materials:
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FSMP registration application form
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Product R&D report, formula design and its theoretical foundation
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Manufacturing process introduce
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Requirements for product quality standard
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Sampling testing report
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R&D, manufacture and testing capability proof
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Other materials that can improve product safety, nutritional sufficient and special medical clinical effect
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Clinical trial report (only specific full nutritional formula foods required)
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Registration application relevant certificates, such as business license in original country
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Other relevant material
Note: 1. when the registration of imported FSMP is to be applied/altered/renewed, the applicant can be representative office in China or agent institute within China. If the applicant is representative office in China,registration certificate for overseas enterprise representative office in China and its copy are required in addition. If the applicant is agent institute within China, notarized letter of commitment andbusiness license of agent institute shall be submitted in addition.
2. Product label and specification shall comply with “Label and Specification Samples of Foods for Special Medical Purpose (for comment)”.
The FSMP registration alternation requires following materials:
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FSMP registration alternation application form
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Copy of product registration certificate and its appendix
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New product label, specification, manufacturing process introduce and other relevant registration application materials
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Name, reason and theoretical foundation of changing part
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The evidence showing that the product has been sold or the explanation making clear why product hasn’t been sold
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Relevant materials and copies about applicant
The applicant shall, no later than 6 months prior to the expiration of the valid period, apply to the CDFA for renewing registration. And applicant shall submit below materials to CDFA:
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FSMP registration renewal application form
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Copy of product registration certificate and its appendix
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Relevant materials and copies about applicant
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FSMP quality safety management specification
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FSMP quality control system self-inspection report
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FSMP tracking assessment report
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Daily supervision record and comments for renewing registration from provincial-level Food and Drug Inspection Department
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Recorded food safety enterprise standard
Please click here to find more information about Administrative Measures of Foods for Special Medical Purpose (FSMP) Registration (trial)(draft).
Contact us
Ms. Cathy Yu Team Leader of Food Safety and Regulatory Affairs Department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel: +86 571 8720 6538 | Fax: +86 571 8720 6533
Email: cathy.yu@cirs-group.com
