Administrative Measures on Foods for Special Medical Purpose (FSMP) Registration and Its Relevant Regulations Took Effect in July 2016 in China

Update on 15 July 2016

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 includeApplication 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)”. “Administrative Measures on Foods for Special Medical Purpose (FSMP) Registration” will come into force on 1 July 2016.

According to “Application Materials and Requirements of Foods for Special Medical Purpose (for comment)”, FSMP registration requires the following materials:

  • FSMP registration application form
  • Product R&D report, formula design and its theoretical foundation
  • Manufacturing process introduce
  • Requirements for product quality standard
  • Sampling testing report
  • R&D, manufacture and testing capability proof
  • Other materials that can improve product safety, nutritional sufficient and special medical clinical effect
  • Clinical trial report (only specific full nutritional formula foods required)
  • Registration application relevant certificates, such as business license in original country
  • 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 and business 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:

  • FSMP registration alternation application form
  • Copy of product registration certificate and its appendix
  • Relevant materials and copies about applicant
  • The evidence showing that the product has been sold or the explanation making clear why product hasn’t been sold
  • Name, reason and theoretical foundation of changing part
  • New product label, specification, manufacturing process materials and other relevant registration application materials

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:

  • FSMP registration renewal application form
  • Copy of product registration certificate and its appendix
  • Relevant materials and copies about applicant
  • FSMP quality safety management specification
  • FSMP quality control system self-inspection report
  • FSMP tracking assessment report
  • Daily supervision record and comments for renewing registration from provincial-level Food and Drug Inspection Department  
  • Recorded food safety enterprise standard

News Update

The Administrative Measures on Foods for Special Medical Purpose Registration has been implemented since 1 July 2016.  Meanwhile, the online application system for FSMP registration is available. The website is http://lt1.zybh.gov.cn/qiye/login/loginAction!login.dhtml

On 15 July 2016, formal versions of “Administrative Measures on Foods for Special Medical Purpose Registration" relevant regulations were issued by CDFA. There are the "Application Materials and Requirements of Foods for Special Medical Purpose (Trail)”“Label and Specification Samples of Foods for Special Medical Purpose (Trail)”, “Stability Research Requirement of Foods for Special Medical Purpose (Trail)” and "Spot Inspection Point and Judging Principle for Manufacturer of Foods for Special Medical Purpose (Trial)".

According to “Application Materials and Requirements of Foods for Special Medical Purpose (Trail)”, FSMP registration requires the following materials:

  • FSMP registration application form
  • Product R&D report, formula design and its theoretical foundation
  • Manufacturing process materials
  • Requirements for product quality standard
  • Product label sample and specification sample (new)
  • Sampling testing reports
  • R&D, manufacture and testing capability proof materials
  • Other materials that can improve product safety, nutritional sufficient and special medical clinical effect
  • Clinical trial report (only specific full nutritional formula foods required)
  • Registration application relevant certificates, such as business license in original country
  • Other relevant material

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:

  • FSMP registration renewal application form
  • Copy of product registration certificate and its appendix
  • Relevant materials and copies about applicant
  • FSMP quality safety management specification
  • FSMP quality control system self-inspection report
  • FSMP tracking assessment report
  • Daily supervision record and comments for renewing registration from provincial-level Food and Drug Inspection Department  
  • Recorded food safety enterprise standard
  • If the registration information of FSMP is different with the product registration certificate and its appendix, the different part shall be indicated. And relevant materials are required to submit. (new)
  • Long term stability research materials (new) if you have promised to continue to do it in the first registration.

The FSMP registration alternation requires following materials:

  • FSMP registration alternation application form
  • Copy of product registration certificate and its appendix
  • Relevant materials and copies about applicant
  • The evidence showing that the product has been sold or the explanation making clear why product hasn’t been sold
  • Name, reason and theoretical foundation of changing part
  • New product label, specification, manufacturing process materials and other relevant registration application materials

Note: 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, the copy of registration certificate for overseas enterprise representative office in China is required in addition. If the applicant is agent institute within China, notarized letter of commitment (and its Chinese translation) and business license of agent institute shall be submitted in addition.

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