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Note: CFDA has been merged into State Administration for Market Regulation (A picture to know the changes of china's food regulation structure)

 1. Background introduction:

1.1 China formula food for special medical purpose (FSMP) market introduction for oversea FSMP manufactures
Ø From the global point of view, the market capacity of FSMP in 2016 was about 64 billion RMB, the scale of European and American markets is 45 billion yuan, and the market size of Japan and South Korea is 18.5 billion yuan. The scale of China's special medical use food market is only 600 million yuan, in which China just accounted for 1% of global share, but the FSMP market in China has rapidly developed in recent years with an average annual growth rate of more than 30%.
Ø With the advent of an aging society, the increased pressure of medical expenses and medical insurance, as well as the increasin attention on the nutritional knowledge and nutritional status, more and more nutritionists, doctors, clinical dietitians and patients attach importance to the use of FSMP in clinic, and the relevant regulations and standards have been gradually improved, thereupon the FSMP market of our country will face new development opportunities.
Ø FSMP will be the third blue ocean in the field of large health field following drug and instrument, and this industry will also meet explosive growth in the near future.
Ø From policy and regulation perspective, healthy regulatory system has been already set up, which can guarantee the industry move forward smoothly. While, from marketing perspective, currently, more than 90% of the FMSP shares in China are monopolized by several multinational companies. Which mainly due to the high requirement of technical capabilities like clinical study, R&D research, etc., Lots of local companies cannot reach to this area.
 
 
1.2 Regulation development review about FSMP in China
Comparing to developed countries and areas, the development of FSMP in China was started later, which is mainly divided into the following 4 stages:
图片1
 
1.3 Summary of FSMP approved in China (Appendix 1)
 
China or abroad
Abroad
China
Total
Amount of Enterprises
13
13
26
Amount of declared products
42
33
75
Total of approval
5
1
6

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Ø The above is the data released in the official statement, the deadline to March 27, 2018.
Ø Most of the declared products are still under review or approval. 

               Appendix 1 Summary of FSMP approved in China 
No.
Enterprise name
Product name
Registration certification No.
Expiration date
Publication date
Category
1
SHS International Ltd
Amino acid formula of  Neocate infant formula milk powder for special medical
State Food Registration No. TY20175001
2022/11/19
0-12 months
Lacto protein deep hydrolysis formula or amino acid formula
2
ABBOTT LABORATORIES S.A.
Lacto protein partial hydrolysis formula of Similac Qinhu infant formula milk powder for special medical use
State Food Registration No.TY20175002
2022/11/19
0-12 months
Lacto protein partial hydrolysis formula
3
ABBOTT LABORATORIES S.A.
Lacto protein partial hydrolysis formula of Eleva Hehu infant formula milk powder for special medical use
State Food Registration No.TY20175003
2022/11/19
0-12 months
Lacto protein partial hydrolysis formula
4
Hangzhou Beingmate Maternal and Infant Nutrition Co., Ltd.
Lactose free formula of Beingmate infant formula food for special medical use
State Food Registration No.TY20180001
2023/2/12
0-12 months
Lactose free formula or low lactose formula
5
SHS International Ltd
 Phenylketonuria formula of Newbery infant formula milk powder for special medical use
State Food Registration TY20185001
2023/2/26
0-12 months
Amino acid metabolism disorder formula
6
Mead Johnson (Holland) Co., Ltd
 Lacto protein partial hydrolysis formula of Qinshu infant formula milk powder for special medical use
State Food Registration No.TY20185002
2023/3/19
0-12 months
 Lacto protein partial hydrolysis formula
 
2. What is FSMP?

2.1 Definition
As especially formulated foods that are produced to meet the special requirements for nutrient or meals of people who suffer from eating limitation, disorder of digestion and absorption, metabolic disorders or special disease state, these products shall be eaten individually or with other foods under the guidance of doctors or clinical dietitians.

2.2 Classification
 
FSMP
FSMP for infants (0-12 mon)
Lactose-free formula food or low lactose formula food
Formula food of partially hydrolyzed lactoprotein
Formula food of deep hydrolyzed lactoprotein or amino acid formula food
Formula food for premature infants or low birth weight infants
Breast milk nutritional supplements
Formula food for disorder of amino acid metabolism
FSMP for the population above 1 yr
Full nutritional formula food
Applicable to 1-10 years crowds.
Applicable to crowds older than 10 years.
          Specific full nutritional formula food
Full nutritional formula food for diabetes
Full nutritional formula food for disease of respiratory system
Full nutritional formula food for nephropathy
Full nutritional formula food for tumour
Full nutritional formula food for hepatopathy
Full nutritional formula food for muscle attenuation syndrome
Full nutritional formula food for trauma, infection, operation and other stringent state
Full nutritional formula food for inflammatory bowel disease
Full nutritional formula food for food protein allergy
Full nutritional formula food for intractable epilepsy
Absorbing barrier of gastrointestinal tract and pancreatitis
Full nutritional formula food for metabolic disorder of fatty acid
Full nutritional formula food for obesity and lose fat operation
Non-full nutritional formula food
Nutrient module
Protein (amino acids) module
Fat (fatty acid) module
Carbohydrate module
Electrolyte formula
Thickening module
Liquid formula
Formula for the disorder of amino acid metabolism
 
3. Regulatory framework for FSMP in China

Regulatory framework
Name
Administrative Department
China Food and Drug Administration (CFDA)
FSMP Registration Regulations
Administrative Measures for Registration of Foods for Special Medical Purpose (2015)
Requirements for Application Materials for Registration of Foods for Special Medical Purpose (Trial) (Revised edition 2017)
Stability Study Requirements for Foods for Special Medical Purpose (For Trial) (Revised edition 2017)w
Label and Instruction of Foods for Special Medical Purpose (Trial) (2016)
Checkpoints and Judgment Principles for Manufacturer Field Inspection for the Registration of Foods for Special Medical Purpose (Trial) (2016)
Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (Trial) (2016)
Relevant standards
Guideline for Formulas for special medical purposes intended for infants (GB 25596-2010)
General Rule on Formulated Foods for Special Medical Purposes (GB 29922-2013)w
Good Manufacturing Practice of Foods for Special Medical Purposes (GB 29923-2013)
Food Labeling of Prepackaged Foods for Special Dietary Supplies (GB 13432-2013)

4. FSMP registration

 
4.1 FSMP registration process
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4.2 Materials submitted for FSMP registration
 
Materials submitted
Ø Application form for registration
Ø Product research and development report and formula design and its basis
Ø Production technology materials
Ø Product standard requirements
Ø Product label and instruction sample manuscript
Ø Inspection report of test sample
Ø documentary materials for R&D, production and inspection abilities;
Ø Clinical test reports and related materials (specific full nutritional formula food shall provide);
Ø Other documentary documents related to registration
Additional materials submitted for imported FSMP
Ø Qualification certificates copy and Chinese translation versions of overseas applicant for registration as the foreign manufacturers issued by government authority of product producing country (area) or legal services corporation.
Ø Copy of documentary evidence and its Chinese translation version of allowed to be sell on the market issued by government authority of product producing country (area) or legal services corporation, the materials cannot be provided if the products are not sold on the market
Ø Where the registration transaction is handled by the representative offices in China of foreign registration applicant, the copy of ‘Registration certificate of representative offices of foreign enterprises in China’ shall be provided
Ø Where the foreign registration applicant entrusts the oversea institutions to handle the registration items, foreign registration applicant shall provide the notarized original copy of certificate of entrustment and its Chinese translation version, and the copy of business license of entrusted institutions
4.3 Special tips about FSMP registration
 
Ø According to related regulations for FSMP, all the FSMP produced in China or exported to China shall acquire the registration certificate issued by CFDA before Jan 1st 2019 and mark the registration number on the label and the instructions.
Ø For the products with different flavors, different colors but basically same formula, CFDA only grant one registration certificate.
Ø Registration of special full nutritional formula food need to be submitted the clinical test reports, CFDA only admit the drug clinical trial institutions with record filing in mainland China.

 
5. Our services

 
Service
Content
 
Required document
review & correction
 
Ø  Step by step process guideline
Ø  Collect and analyze materials from client
Ø  Supplement and revision opinions
Ø  Advice on modification in order to meet China statutory requirements
 
Sample inspection
Ø Sample receiving and tracking
Ø  Arrange sample inspection
Ø  Track inspection progress & handles problems
Ø  Inspection report review  
Clinical trials (specific full nutrition)
Ø  Preparation of clinical inspection required information,
Ø  Submit clinical submission data and samples,
Ø  Tracking the progress & handle problems
Ø  Clinical trial reports review. .
Dossier preparation
Ø Build up dossier storyline structure 
Ø Consolidate draft from English to Chinese
Dossier Submission
online submission
On-site submission
 
Progress following up
Ø Follow up the CFDA review process
Ø Face to face talking with CFDA and supplement required documents accordingly

Contacts

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Email:global-service@foodmate.net
ADD: W. 4th Ring Road North No.160 Haidian Beijing China

 

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Email:hanking@foodmate.net
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Email: EUoffice@foodmate.net
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