With the increasing number of ageing 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 100 billion US dollars, which will be the next blue ocean after infant formula and health food.

1. Your End to End Food
Regulatory Service
Provider in China
Regulatory Process Guideline to Export Formula Food
for Special Medical Purpose (FSMP) Product to China
Emily Xu (emily@foodmate.net)
China Food Regulation Consultant
info.foodmate.com

2. Introduction
2
ü 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.
ü 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.
ü 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
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

4. Ø 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.
Ø 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
1970—2000
Emphasis
2002—2009 2009—2015 2016—Future
Ø In 1974, Beijing had a report on the clinical
application of FSMP
Ø With the development of clinical nutrition,
the clinical effects and social values of
FSMP was recognized
Ø FSMP was firstly classified by China Medical
Association.
Ø The importance of correct nutrient consumption
was stated in China Nutrition Improvement
Action Plan
Ø China issued requirements for technology and
function of FSMP.
Ø FSMP was clarified in the new China Food
Safety Law
Ø 2 products standards and 1 manufacture
standard were issued
Ø CFDA issued the “Administrative Measures
for the Registration of Formula Foods for
Special Medical Uses (Trial)
Ø Special food registration department
was established
Ø 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. 6
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)
Ø Proportion of enteral nutrition and
parenteral nutrition in developed countries
is 10: 1, while in China it is only 1: 5-15【2】
Ø 65% of malnourished patients use FSMP in
USA and 27% in UK, while only 1.6 in
China use FSMP 【3】
Ø 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

7. Agenda
7
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

8. 8
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

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

10. Agenda
10
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

11. 1 Good manufacture standard + 2 Product standards
11
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

12. 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
12
3.1 China FSMP GB structure

13. 13
Laws, regulations, standards related to FSMP in China
3.1 China FSMP GB structure
ü Article 74：The state carries out strict supervision and
management of special foods such as health food,
FSMP and infant formula food
ü Article 80：FSMP shall be registered by the food and
drug administration department under the State
Council
I. Food Safety Law
II. National food safety standards (GB)s
ü GB 25596-2010 National food safety standard General
provisions for infant formula for special medical
purpose
ü GB 29922-2013 National food safety standard General
provisions for food for special medical purpose
ü GB 14880-2012 National food safety standard The use
standard of food nutrition fortifier
ü GB 2760-2014 National food safety standard The use
standard of food additives
ü GB 13432-2013 National food safety standard Label
for pre-package special foods
ü GB 7718-2011 National food safety standard The
general principles of the prepackaged food labels
ü GB 29923-2013 National food safety standard food for
special medical purpose enterprise good
manufacturing practices
III. FSMP Registration Regulations
ü Administrative Measures for Registration of Foods
for Special Medical Purpose (2015)
ü FSMP label, instructions sample draft requirement
(trial)（2016）
ü FSMP clinical trial quality management
specification (trial)（2016）
ü FSMP registered production companies on-site
check points and judgment principles (trial)（2016）
ü FSMP registration application items and
requirements (Trial) (2017 Revision)
ü FSMP stability study requirements (trial) (2017
Revision)
ü Special food registration on-site verification of
implementation specifications (draft) （2017）
ü FSMP clinical guidelines for inflammatory bowel
disease（draft for soliciting opinions）（2017)
ü FSMP clinical trial guidelines（draft for soliciting
opinions）（2017）
ü FSMP guiding principles for clinical trials of
nephropathy (draft for soliciting opinions)（2018）
ü FSMP muscular decay syndrome clinical trial
guidelines（draft for soliciting opinions）（2018）
ü Detailed rules for the examination of production
license of FSMP (draft for soliciting opinions)
(2018)

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

15. 15
Required document list for FSMP registration in China
3.2 China FSMP registration
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 materials related to registration

16. Agenda
16
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

17. 17
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 requirement
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 Ø online submission
Ø On-site submission
Progress following up Ø Follow up the SAMR review process
Ø Face to face talking with SAMR and supplement required
documents accordingly
Foodmate consulting service for FSMP registration in China
4 Foodmate service

18. Stay in China—Example for safety and regulatory
information monitoring
18
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Covering
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expert interpretations
• Possible regulation updates
• Risk alert, recommended solutions
Helping you
• Get the most valuable & reliable information
with much lower cost
• Act timely in front of regulation changes and risks
Example of FoodMate monthly
regulation intelligence report for
an international dairy company
Be Your China Back Office to Navigate and Protect Your Sail in China
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19. 19
Contact us
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Dairy related clients in China
4 Foodmate Services
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Beijing
Phone: +86 13391855879
E-mail: emily@foodmate.net
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20. 20
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