"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration

1. CFDA
CCFDIE
1
Brief Introduction of
China Food and Drug Administration
Chang Yongheng
China Center for Food and Drug International Exchange
China Food and Drug Administration
April 9, 2014

2. CFDA
CCFDIE
April 9, 2014 2
Content
 Background
 Focus of Reform
 CFDA Internal Offices and Main Responsibilities
 Division of Regulatory Authority among Ministries
 Division of Regulatory Authority between CFDA and
local FDA

3. CFDA
CCFDIE
3
Background
Regulatory Model before Reform
 Production Quality Inspection agency
 Distribution Industry &Commerce agency
 Catering Food and Drug agency
……
April 9, 2014

4. CFDA
CCFDIE
4
Focus of Reform
1. Integrate and centralize food safety
regulatory authority.
April 9, 2014

5. CFDA
CCFDIE
5
Focus of Reform
2. Streamline and strengthen responsibility of
different Ministries, co-operation to ensure
food safety.
3. Establish and improve grass-roots food and
drug management system.
April 9, 2014

6. CFDA
CCFDIE
6
Focus of Reform
4. Consolidate food and drug regulatory authority.
April 9, 2014

7. CFDA
CCFDIE
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Focus of Reform
5. Strengthen and elevate food and drug
regulatory capacity.
6. Transform and optimize government
functions.
CFDA cancels 4 administrative licensing items,
delegate 5 items and integrate 5 items.
April 9, 2014

8. CFDA
CCFDIE
State Council
8
CFDA Internal Offices and Main
Responsibilities
CFDA has administrative staffing of 345
17 Internal Offices
Ministerial-level Agency
… …
SAWS
SAIC
AQSIQ
CFDA
April 9, 2014

9. CFDA
CCFDIE
9
CFDA Internal Offices and Main
Responsibilities
 CFDA Main Responsibilities
 1. Draft and formulate laws, regulations and normative documents;
 2. Formulate the regulations on food administrative licensing and
supervise its implementation;
 3. Organize the formulation and publication of drug and medical
device standards and classification system, and supervise their
implementation;
 4. Formulate the investigation and enforcement system and
organize its implementation;
 5. Establish food and drug emergency response system;
 6. Formulate science and technology development plans for food
and drug safety, and organize its implementation.
April 9, 2014

10. CFDA
CCFDIE
10
CFDA Internal Offices and Main
Responsibilities
7 Departments
of Administration
General
Office
Comprehensive
Department
Department
of Media
and Publicity
Department
of Legal
Affairs
Department
of Human
Resources
Department of
International
Cooperation
(Office of
Hong Kong,
Macao and
Taiwan Affairs)
Department
of Planning
& Finance
April 9, 2014

11. CFDA
CCFDIE
11
CFDA Internal Offices and Main
Responsibilities
10 Departments
of Operation
3 departments
of food
2 departments
of drug
&cosmetics
2 departments
of medical
device
3 other
departments
April 9, 2014

12. CFDA
CCFDIE
12
CFDA Internal Offices and Main
Responsibilities
3 Departments
of Food
Department of
Food Safety
Supervision I
Department of
Food Safety
Supervision II
Department of
Food Safety
Supervision III
April 9, 2014

13. CFDA
CCFDIE
13
CFDA Internal Offices and Main
Responsibilities
2 Departments
of Drug
& Cosmetics
Dept. of
Drug and Cosmetics
Registration
Dept.
of Drug and
Cosmetics
Supervision
April 9, 2014

14. CFDA
CCFDIE
14
CFDA Internal Offices and Main
Responsibilities
2 Departments
of Medical
Device
Dept. of
Medical Device
Registration
Dept. of
Medical Device
Supervision
April 9, 2014

15. CFDA
CCFDIE
15
CFDA Internal Offices and Main
Responsibilities
3 Other
Departments
Dept.
of Science and
Technology
Bureau of
Investigation
and Enforcement
Dept.
of Emergency
Management
April 9, 2014

16. CFDA
CCFDIE
16
Main Affiliated Institutions and Responsibilities
National Committee on the Assessment of
the Protected Traditional Chinese Medicinal
Products (Center for Health Food Evaluation)）
Center for Medical Device Evaluation
Center for Complaints and Report
National Institutes for Food and Drug Control
(Center for Medical Device Standardization
Administration)
Chinese Pharmacopoeia Commission
Center for Drug Evaluation
投诉举报中心
National statutory Institutions and the highest
technical arbitration body for drugs and biological products
Organize Chinese Pharmacopoei compilation, formulate
and revise national Pharmaceutical standards as
statutory national drug standard management agency
Undertake national TCM protection and
technical review of health food, cosmetics approval
Responsible for technical review of drug registration appli-
cations as CFDA Drug Registration technical review Agency
Responsible for technical review of import medical
devices and domestic Class Ⅲ medical Devices
Accept complaints for illegal activities in medicines, medical
devices, health food and cosmetics in development,production,
distribution, use and catering food service
Responsible for conducting pharmaceutical / medical device
Adverse Reactions / events monitoring at home and abroad
Center for Drug Reevaluation (National
Center for ADR Monitoring)
April 9, 2014
China Center for Food and Drug
International Exchange (CCFDIE)
Responsible for international exchange and cooperation
activities with international organizations or the industry

17. CFDA
CCFDIE
17
Division of Regulatory Authority
among Ministries
I. Food safety regulatory authority are
converging.
Main Regulatory Agency：5 2

18. CFDA
CCFDIE
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Division of Regulatory Authority
among Ministries
 II. Administrative convergence mechanism
gradually established.
 Food safety track system
 CFDA Ministry of Agriculture
 Import and export food safety information rapid
notification system
 CFDA AQSIQ
 Food safety risk assessment and standard
coordination system
 CFDA NHFPC
April 9, 2014

19. CFDA
CCFDIE Division of Regulatory Authority
among Ministries
III. Judicial linkage mechanism gradually
improved.
 CFDA Ministry of Public
Security
April 9, 2014

20. CFDA
CCFDIE
20
Division of Regulatory Authority
between CFDA and local FDA
Goal
upper and lower linkage
joint push pull
smooth operation
overall improvement
April 9, 2014

21. CFDA
CCFDIE
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Division of Regulatory Authority
between CFDA and local FDA
 Drug regulation
 CFDA is responsible for review and approval of new
drugs and generic drug registration.
 Local FDA is responsible for daily supervision and
inspection of listed companies within areas under its
jurisdiction.
April 9, 2014

22. CFDA
CCFDIE
22
Division of Regulatory Authority
between CFDA and local FDA
 Medical Device Regulation
 CFDA is responsible for review and approval of
Class Ⅲ and import medical device registration.
 Local FDA is responsible for ClassⅠand Ⅱmedical
device registration, as well as daily supervision and
inspection of listed companies within areas under its
jurisdiction.
April 9, 2014

23. CFDA
CCFDIE
23
Division of Regulatory Authority
between CFDA and local FDA
 Food safety supervision
 CFDA is responsible for formulating policies, annual
plans and unified information publication system.
 Local FDA is responsible for administrative
licensings , daily supervision and inspection of listed
companies within areas under its jurisdiction.
April 9, 2014

24. CFDA
CCFDIE
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Thanks for your Attention！
April 9, 2014