On Mar. 10, 2016, China Food and Drug Administration (CFDA) released the final version of “Administrative Measures for Registration of Foods for Special Medical Purpose”, which will be put into force from Jul. 1, 2016.
This regulation is applicable to both FSMPs for infants (0-12 months) and FSMPs for the population above 1 year old. However, it does not apply to the nutritious meals prepared by medical institutes for patients.
China FSMP Premarket Guideline
Administrative Measures for Registration of Foods for Special Medical Purpose
Requirements for field inspection:
The requirements on field inspection and technical review have been further specified. Field will include inspection on the authenticity, completeness and accuracy of clinical testing, as well as the R&D, production and inspection capabilities of the applicant.
Optimized registration approval procedure:
The procedures for registration application and approval have been optimized and specific time limits for each step of approval have been designated.
Legal liabilities for violation:
In cases where false information is given during the application for registration, the applicant will be prohibited from reapplication for one year.
In cases where the registration certificate is obtained by illegal means, the applicant will be prohibited for reapplication for three years and issued a maximum fine of RMB 30,000.
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