Food for Special Medical Purpose

Food for special medical purpose (FSMP) refers to a category of foods specially processed or formulated to meet the special nutritional demands of consumers with a limited, impaired or disturbed capacity to intake, digest, absorb or metabolize conventional foods, or consumers with a particular disease or condition, including FSMPs for infants (0-12 months) and FSMPs for the population above 1 year old.

Requirements

According to Food Safety Law, food for special medical purposes shall be registered with CFDA by providing product formula, production techniques, labels, instructions as well as the materials that prove the product safety, nutrition sufficiency and clinic effect of special medical purpose.

From Jan. 1, 2018, all FSMPs manufactured within China or imported to China should be registered with CFDA prior to the sale in Chinese market.

Administrative department

China Food and Drug Administration (CFDA)

Relevant regulations

  • Administrative Measures for Registration of Foods for Special Medical Purpose
  • Label and Instruction of Foods for Special Medical Purpose (Trial) 
  • Stability Study Requirements for Foods for Special Medical Purpose (For Trial) 
  • Requirements for Application Materials for Registration of Foods for Special Medical Purpose (Trial) 
  • Checkpoints and Judgment Principles for Manufacturer Field Inspection for the Registration of Foods for Special Medical Purpose (Trial) 
  • Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (Trial)

Penalties

According to Food Safety Law, if producers or traders of FSMPs violate the Law by engaging in unauthorized or illegal production or trading activities, the illegally gained benefits/FSMPs and the tools, equipment and raw material used for production or trading will be confiscated. The producer or trader is also subject to a fine between RMB 50,000 to 100,000 if the total value of the commodity is less than RMB 10,000, or a fine between 10 and 20 times if the total value of the commodity exceeds RMB 10,000; for severe violation of the law, the business license of food producers and traders will be revoked.

REACH24H Service

Free regulatory consultation

Communication via internet, telephone and face-to-face

Main content:

1) Management regulations of FSMP

2) Registration procedure of FSMP

3) Registration strategies of FSMP

4) Customized consultation and training

Compliance review

Check if the FSMP complies with Chinese regulations

Main content:

1)      Product formula review

2)      Label review

3)      Ingredients and additives review

4)      Consultation on product R&D

Pre-review of product registration

Evaluate the capacity of R&D, testing and production of the manufacturer

Main content:

1) Qualification review of the manufacturer

2) R&D materials review

3) On-site factory audit

4) Communication with experts and competent authorities

FSMP registration

Get the administrative approval of FSMPs

Main content:

1) Preliminary evaluation: feasibility, timeline and cost

2) Dossier preparation and submission

3) Test monitoring for registration

4) Clinical test monitoring

4) Communication with experts and evaluation department 

contact us


  • Tel: 0571-87007036
  • Fax: 0571-87007566
  • Add: 14th Floor, Building No. 3, Haichuang Technology Center, 1288 West Wen Yi Road, Hangzhou, China 311121
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