With the increasing number if aging population and huge number of chronic disease patients, China has a booming demand in FSMP. Compare to the global 56-64 billion US dollars sales volume, while China only takes account 1% of the market share. It is estimated that in the following 10 years, China’s FSMP sales volume will reach to 600 billion RMB, which will be the next blue ocean after infant formula and health food. From government perspective, China has issued series of policies and regulations to support FSMP industry including Health China 2030 National Plan, China's medium & long term plan to prevent & cure chronic diseases (2017 - 2025), Special plan for science and technology innovation of health industry in 13th Five-Year, FSMP registration regulation. Which are all aimed to improve and promote the FSMP industry development. Besides, due to China’s domestic FSMP can still not meet the local demand, government also decreased the import tariff for some of FSMP and let high quality product to enter to China market. As a leading China food regulation consulting company, Foodmate developed this report to outline challenges for foreign companies to exporting FSMP to China. An in depth regulation mapping and step by step compliance guideline of exporting FSMP to China is also interpreted in this report.

1. Regulatory process guideline to export formula food for
special medical purpose (FSMP) product to China
FoodMate China –China food regulation consultant
Rong Liu （liurong@foodmate.net）

2. Introduction
2
With the increasing number if aging population and huge number of chronic disease
patients, China has a booming demand in FSMP. Compare to the global 56-64 billion US
dollars sales volume, while China only takes account 1% of the market share. It is
estimated that in the following 10 years, China’s FSMP sales volume will reach to 600
billion RMB, which will be the next blue ocean after infant formula and health food.
From government perspective, China has issued series of policies and regulations to
support FSMP industry including Health China 2030 National Plan, China's medium & long
term plan to prevent & cure chronic diseases (2017 - 2025), Special plan for science and
technology innovation of health industry in 13th Five-Year, FSMP registration regulation.
Which are all aimed to improve and promote the FSMP industry development. Besides, due
to China’s domestic FSMP can still not meet the local demand, government also decreased
the import tariff for some of FSMP and let high quality product to enter to China market.
As a leading China food regulation consulting company, Foodmate developed this report to
outline challenges for foreign companies to exporting FSMP to China. An in depth
regulation mapping and step by step compliance guideline of exporting FSMP to China is
also interpreted in this report.

3. Agenda
3
1
2
3
4

4.  When the target population is unable to eat regular meals or cannot meet their nutritional needs with
daily diets, FSMP can serve as a nutritional supplementation pathway, play a nutritional support role,
and can better adapt to the nutritional needs of a particular disease state or disease stage. Provide
targeted nutritional support for patients.
 FMP is not a medicine and cannot substitute for the therapeutic effect of the medicine. Can not claim
functions of prevention / treatment of diseases.
FSMP definition in China
4
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 alone or with other foods
under the guidance of doctors or clinical dietitians.
——(GB 29922—2013 China food safety standards for FSMP)
Definition
Interpretation
1 FSMP regulation development

5. 5
Initial
1970—2000
Emphasis
2002—2009
Improvement
2009—2015
Standardization
2016—Future
 In 1974, Beijing had a report on the clinical
application of FSMP
 With the development of clinical nutrition,
the clinical effects and social values of
FSMP was recognized
 FSMP was firstly classified by China Medical
Association.
 The importance of correct nutrient consumption
was stated in China Nutrition Improvement
Action Plan
 China issued requirements for technology and
function of FSMP.
 FSMP was clarified in the new China Food
Safety Law
 2 products standards and 1 manufacture
standard were issued
 CFDA issued the “Administrative Measures
for the Registration of Formula Foods for
Special Medical Uses (Trial)
 Special food registration department
was established
 FSMP enters to standard product
registration, production and promotion
After nearly 50 years development, China has set up a strict
and comprehensive food regulation system for FSMP
1 FSMP regulation development

6. No. Enterprise name Category
1 SHS International Ltd
Lacto protein deep hydrolysis
formula or amino acid formula
2 ABBOTT LABORATORIES S.A.
Lacto protein partial hydrolysis
formula
3 ABBOTT LABORATORIES S.A.
Lacto protein partial hydrolysis
formula
4
Hangzhou Beingmate Maternal
and Infant Nutrition Co., Ltd.
Lactose free formula or low
lactose formula
5 SHS International Ltd
Amino acid metabolism disorder
formula
6
Mead Johnson (Holland) Co.,
Ltd
Lacto protein partial hydrolysis
formula
6
FSMP product market overview before & after FSMP
registration regulation issued
Due to the requirement of high R&D capability, China FSMP market is dominated by international
companies. For Chinese local FSMP product are mainly imitation of foreign products, which has
small market share and small brand influence.
With the positive policy and registration regulations, both Chinese domestic and oversea FSMP
companies will catch up the opportunity and win FSMP market share in the future.
1 FSMP market development
From 1st January , 2019, all FSMP products in China’s market should be registered, of which
manufacture date are before December 31st , 2018, can be sold till expiration.
(November, 2017 issued by CFDA)
 There are about 69 products, covering
19 categories.
 Most of them were imported to China
since 1980s and dominated by
international companies like Abbott
Pharmaceutical Co., Ltd., Nestle ,
NUTRICIA.
 Domestic products take only 10% of the
total market .
Before After

7. 7
Date Source
【1】Intellengece Research Group (Zhiyan.org）
【2】Peking Union Medical College Hospital,
【3】CHINA FOOD INDUSTRY PRODUCTIVITY PROMOTION CENTE
China FSMP increased rate during last 7 years【1】
China has huge demand for FSMP
China FSMP was increased by 4 times and still has a
huge market demand
1 FSMP market development
0.84
1.02
1.25
1.58
2.01
2.59
3.37
0.65
0.83
1.05
1.55
2.1
2.87
3.66
0
1
2
3
4
2011 2012 2013 2014 2015 2016 2017
Sales volume(unit: billion RMB)
Market demand volume (unit: 10,000 tons)
 Proportion of enteral nutrition and
parenteral nutrition in developed countries
is 10: 1, while in China it is only 1: 5-15
【2】
 65% of malnourished patients use FSMP in
USA and 27% in UK, while only 1.6 in
China use FSMP 【3】
 At least 70% of the demand for FSMP in
China needs to be satisified.【3】
During last 7 years, FSMP product has
increased by 4 times from sales volume
perspective and with 30% annual average
growth rate in China
20
200
200
150
300
0 100 200 300 400
Pregnant women
Children
Old people
Hospitalized patients
Out-of-hospital patients
Unit: million

8. Agenda
8
1
2
3
4

9. 9
Increasing demand for FSMP will reach to 600 billion in 5-
10 years due to
• Ageing of population
• An increasing number of population in chronic disease
Series of policies to support FSMP industry development
• Health China 2030 National Plan
• China's medium &long term plan to prevent & cure chronic diseases
Special plan for science and technology innovation of health industry
Reducing FSMP import tariff and support high quality
products to import to China
• On November 2017, China adjust several FSMP tariff from 20% to 0
including milk protein partial hydrolysis formula, milk protein deep
hydrolysis formula, amino acid formula, lactose free infant formula
With huge/increasing demand and positive policy support,,
imported FSMP will win booming business in China market
2 Opportunities for imported FSMP

10. Unfamiliar with Unclear of Unreachable of Fail to
Challenges for foreign infant formula companies
2 Challenges for imported FSMP
General challenges for foreign companies exporting food to China
Specific challenges for FSMP companies
FSMP
 Related regulations/standards of FSMP products
 Registration requirement for FSMP
 Clinical requirement and implementation in China
 Stability study both long term and accelerate stability study
 Labeling requirement
 More and detail requirement for the dossier like packaging material
research, research on cross pollution for shared production line, etc.

11. Agenda
11
1
2
3
4

12. 1 Good manufacture standard + 2 Product standards
12
GB29923-2013
National food safety standard
Good manufacturing practice
for formula food for special
medical purposes
GB25596-2010
National food safety standard
formula foods for special
medical purposes intended
for Infant (below 1 year)
GB29922-2013
National food safety standard
General provisions for formula
foods for special medical
Purposes (above 1 year)
Manufacturing standard Product standards
Current status of China's
FSMP standards
3.1 China FSMP GB structure

13. FSMP
FSMP for infants
(0-12 mon)
Lactose-free formula food or low lactose formula
Formula of partially hydrolyzed lactoprotein
Formula of deep hydrolyzed lactoprotein or amino acid formula
Formula for premature infants or low birth weight infants
Breast milk nutritional supplements
Formula for disorder of amino acid metabolism
FSMP for the
population above
1 year
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
2 big FSMP categories + 28 specific FSMP products
13
3.1 China FSMP GB structure

14. 14
Food Safety
Law
Article 74：The state carries out strict supervision and management of special foods such as
health food, FSMP and infant formula food
Article 80：FSMP shall be registered by the food and drug administration department under
the State Council
National food
safety
standards
(GB)
GB 25596-2010 National food safety standard General provisions for infant formula for
special medical purpose
GB 29922-2013 National food safety standard General provisions for food for special
medical purpose
GB 14880-2012 National food safety standard The use standard of food nutrition fortifier
GB 2760-2014 National food safety standard The use standard of food additives
GB 13432-2013 National food safety standard Label for pre-package special foods
GB 7718-2011 National food safety standard The general principles of the prepackaged food
labels
GB 29923-2013 National food safety standard food for special medical purpose enterprise
good manufacturing practices
Laws, regulations, standards related to FSMP in China
3.1 China FSMP GB structure

15. FSMP registration announcements from 2015
15
FSMP
Registration
Regulations
Administrative Measures for Registration of Foods for Special Medical Purpose (2015)
FSMP label, instructions sample draft requirement (trial)（2016）
FSMP clinical trial quality management specification (trial)（2016）
FSMP registered production companies on-site check points and judgment principles (trial)
（2016）
FSMP registration application items and requirements (Trial) (2017 Revision)
FSMP stability study requirements (trial) (2017 Revision)
Special food registration on-site verification of implementation specifications (draft) （2017）
FSMP clinical guidelines for inflammatory bowel disease（draft for soliciting opinions）（2017)
FSMP clinical trial guidelines（draft for soliciting opinions）（2017）
FSMP guiding principles for clinical trials of nephropathy (draft for soliciting opinions)（2018）
FSMP muscular decay syndrome clinical trial guidelines（draft for soliciting opinions）（2018）
3.2 China FSMP registration

16. CFDA ID Onsite
auditing
(20 working days)
To be completed
(5 working days)
Review time could be
extended to 30 days If
any exceptional situation.
CFDA ED Sampling
&detection
(30 working days)
CFDA ID Clinical
data review
(40 working days)
CFDA ED Evaluation conclusion
(60 working days)
Submit to CFDA RD
Dossier preparation
Incomplete information
Applicants can submit required
Documents to CFDA ED in 6
months.
CFDA Make decision whether it
is approve or not to register
(20 working days)
Registration approval
(10 working days)
CFDA: China Food and Drug Administration; RD: Receiving department; ED: Evaluation department; ID: Inspection department
FSMP registration process in China
Registration rejection
(10 working days)
Incomplete information
3.2 China FSMP registration

17. 1. Application form for registration
2. Product R&D report , formula design and its basis
3. Production technology materials
4. Product standard requirements
5. Product label and instruction sample manuscript
6. Sample detection report
7. Documentary materials for R&D, production and inspection abilities
8. Clinical test reports and related materials (specific full nutritional formula
food shall provide)
9. Other documentary documents related to registration
17
Required document list for FSMP registration in China
3.2 China FSMP registration

18. 18
3.2 China FSMP registration
1. Application form for registration

19. 2. Product R&D report ,formula design and its basis
Summarize of product R&D purpose, R&D status, and major results
• Ingredients/Raw materials selection process
• Applicable population
• Production process research
• Product standards draft process and basis of each parameters
• Control plan for the migration of hazardous materials in packaging materials and containers
Stability study data
2.1 Product R&D report
3.2 China FSMP registration

20. 2. Product R&D report, formula design and its basis
 Food ingredients, food supplements, nutritional fortifiers, and food additives in the formula shall
comply with relevant national food safety standards and/or relevant regulations, and may not add
nutrients and other biologically active substances other than those specified in standards.
 Food ingredients, food supplements, nutritional fortifiers, and food additives used in the formula
should use standard and standardized names.
 Formulas should indicate the amount of food ingredients, food supplements, nutritional fortifiers, and
food additive used per 1000 g (grams), or per 1000 ml (ml), or per 1000 formula units of the product
(including processing aids used in the production process).
 The amount of energy (kJ or kcal), nutrients, and optional ingredients in 100g (grams), and/or 100ml
(milliliters) and 100kJ (kilojoules) should be indicated. The amount of energy (kJ or kcal), nutrients,
and optional ingredients per serving contains is optional to be labeled
 Energy, nutrients, and optional ingredients should meet the requirements of GB 25596 and
GB 29922.
2.2 Product formula
3.2 China FSMP registration

21. 2. Product R&D report , formula design and its basis
Product formula design shall comply with GB25596 and GB29922
FSMP for infants & Full nutritional formula food
Specific full nutritional formula food & Non-full nutritional formula food
 Characteristics/ principles of the formula, nutritional characteristics of the product should be
described and illustrated.
 Energy, nutrient composition characteristics, applicable population, and the determination
basis for the content of each component (excluding food additives) should be provided.
 Dossier should indicate that the product is safe for eating and contains adequate nutrients.
 Scientific literature and experimental research data on clinical effects of special medical
applications should be provided.
2.3 Product formula design
3.2 China FSMP registration

22. 3. Production technology materials
 Production process description
 Production plant and equipment description
 Key steps/points and quality control measures which may affect product quality
 When different products share the same collinear process, should provide effective
measures to prevent cross-contamination and related materials support
 Production flow chart and step by step description
3.2 China FSMP registration

23.  Food ingredients, food supplements, nutritional fortifiers, and food additives in the formula
 Packaging materials and containers should comply with China related standards
 Sensory requirement
 Energy, mandatory nutrients, complementary nutrients should comply with China regulations
 Contaminates like heavy metal, mycotoxin ,microorganism should comply with China
standards
 Net weight
 Other requirement
4. Product standard requirements
3.2 China FSMP registration

24. 5. Product label and instruction sample manuscript
 Product category
 Product name
 Ingredient list
 Nutritional table
 Formula characteristics / nutritional characteristics
 Product form (liquid/powder)
 Suitable crowd
 Eating method and consumption dosage
 Net weight and specification
 Shelf life
 Storage condition
 Warnings and important notes
 Above 12 items will be evaluated during
CFDA technical review
 The labels and specifications of listed
products should also comply with relevant
laws, regulations, rules and regulations of
national food safety standards
3.2 China FSMP registration
5.1 12 items for FSMP labeling

25.  Characteristics of the formula and nutrients should be described.
 Diseases and medical conditions of applicable populations should
be indicated.
 Characteristics of the energy, nutrients and design basis should
be interpreted.
 Description should be objective, clear and concise.
 Exaggerated and absolute words such as “special”, “optimal” and
“advanced craft” can not be used.
 Words involve disease prevention or treatment are forbidden.
 Functional claims are not allowed.
 Irrelevant information to formula and nutritional characteristics
should not be used.
5. Product label and instruction sample manuscript
3.2 China FSMP registration
5.2 Formula/Nutritional characteristics

26. 26
6. Sample detection report and stability test
 Sample detection report
• 3 batches samples should produce in commercial production line and comply with GB 29923
• 3 batches samples full items detection
• All of the detection result and judged conclusion should be indicated
 Stability study
• Should comply with the requirement of FSMP stability study requirements (trial) (2017 Revision)
• Samples should produce in commercial production line and comply with GB 29923
• Accelerated stability test should be ¼ of shelf life and no less than 3 months
• Specific full nutritional formula food & non-full nutritional formula food registration dossier should
include stability study data
• Full nutritional formula food and FSMP for infant registration dossier, it is not necessary to
provide stability study data, while the study should be conducted and prepared for onsite audit.
3.2 China FSMP registration

27. 27
7.8.9 Other requirement for FSMP registration
7. Document to support R&D, production, inspection capabilities
8. Clinical trail only applies for specific full nutritional formula food, which should be
conducted under the guidance of FSMP clinical trial quality management specification
(trial)
9. Other documentary documents related to registration
 Certificate of registration of the applicant's main body
 Trademark certification and supported document
 Import product certification document
3.2 China FSMP registration

28. Agenda
28
FMSP China regulation & market development
Opportunities & Challenges for foreign FSMP
companies enter to China
Step by step compliance guideline and
regulation mapping
Foodmate service for you
1
2
3
4

29. 29
Service Content
Required document
review & correction
 Step by step process guideline
 Collect and analyze materials from client
 Supplement and revision opinions
 Advice on modification in order to meet China statutory requirement
Sample inspection  Sample receiving and tracking
 Arrange sample inspection
 Track inspection progress & handles problems
 Inspection report review
Clinical trials
(specific full nutrition)
 Preparation of clinical inspection required information
 Submit clinical submission data and samples
 Tracking the progress & handle problems
 Clinical trial reports review.
Dossier preparation  Build up dossier storyline structure
 Consolidate draft from English to Chinese
Dossier Submission  online submission
 On-site submission
Progress following up  Follow up the CFDA review process
 Face to face talking with CFDA and supplement required
documents accordingly
Foodmate consulting service for FSMP registration in China
4 Foodmate service

30. Contact us
Your Reliable Food Regulation Service Provider
30
Thank you
Website: http://info.foodmate.com/
E-mail: liurong@foodmate.net
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