China FSMPs: New Regulations for Foods for Special Medical Purposes Released

On Sep. 2, 2015, CFDA released the draft of “Administrative Measures for Registration of Foods for Special Medical Purpose”, which will be open for public consultation until Oct. 1, 2015. 

Under the new regulatory environment, foods for special medical purposes (FSMPs) will be required to be registered with CFDA prior to sale in Chinese market.

Applicable scope:

This regulation is applicable to both FSMPs for infants (0-12 months) and FSMPs for the population above 1 year old, and is also applicable to both domestically produced and imported FSMPs.

Competent authority:

CFDA will take charge of the registration of FSMPs, and will organize relevant experts to review the product registration.

Application dossiers for FSMPs registration:

• 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

FSMPs re-registration:

The validity period of an FSMP registration certificate will be five years. The application for re-registration should be made 60 days before the expiry of the certificate by submitting the following dossiers:

• Application form for re-registration of FSMPs

• FSMPs registration certificate

• Detailed information regarding product manufacturing, sale and sampling inspection during the 5 years, as well as the statements for the unqualified products

• Conclusions of product use condition and adverse reactions within the 5 years

Labeling requirements:

There should not be any claims relating to disease prevention and/or indications of curative functions.

There should be obvious indications of “use under the guidance of doctors or clinical dieticians”, “this product is unsuitable for non-target consumer groups”, and “this product is prohibited for parenteral nutritional support and intravenous injection”.