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CFDA Releases Draft Regulations for Food with Special Medical Purposes

October 16, 2015

CHINA - The China Food and Drug Administration (CFDA) has released draft regulations for food with special medical purposes through the Administrative Measures for Registration of Foods for Special Medical Purposes (FSMP).

The measures require manufacturers of food for special medical purposes to be registered with CFDA and the following documentation will be required to be submitted to the agency:

  • Application form for FSMPs registration
  • Product R&D report and product formula and relevant evidences
  • Production process
  • Product quality standards and requirements
  • Product label and users’ directions
  • Sample test report
  • Materials proving the capabilities of R&D, production and inspection
  • Other materials proving the product safety and nutrient sufficiency
  • Clinic test report is required for the registration of nutritionally complete foods with a specific formulation

The draft measure is applicable to food manufactured for medical purposes and intended for infants (0-12 months) and FSMPs for the population above 1 year old, and is applicable to both domestically produced and imported FSMPs.

Public consultation was open through October 1, 2015.

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