Brief Introduction to China FDA 2014
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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
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"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration
Transcript of Brief Introduction to China FDA 2014
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
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
CFDA CCFDIE
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Background
Regulatory Model before Reform
Production Quality Inspection agency
Distribution Industry &Commerce agency
Catering Food and Drug agency
……
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Focus of Reform
1. Integrate and centralize food safety
regulatory authority.
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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.
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Focus of Reform
4. Consolidate food and drug regulatory authority.
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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
CFDA CCFDIE
State Council
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CFDA Internal Offices and Main
Responsibilities
CFDA has administrative staffing of 345
17 Internal Offices
Ministerial-level Agency
… …
SA
WS
SA
IC
AQ
SIQ
CF
DA
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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.
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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
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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
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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
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CFDA Internal Offices and Main
Responsibilities
2 Departments
of Drug
& Cosmetics
Dept. of
Drug and Cosmetics
Registration
Dept.
of Drug and
Cosmetics
Supervision
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CFDA Internal Offices and Main
Responsibilities
2 Departments
of Medical
Device
Dept. of
Medical Device
Registration
Dept. of
Medical Device
Supervision
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CFDA Internal Offices and Main
Responsibilities
3 Other
Departments
Dept.
of Science and
Technology
Bureau of
Investigation
and Enforcement
Dept.
of Emergency
Management
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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)
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China Center for Food and Drug
International Exchange (CCFDIE)
Responsible for international exchange and cooperation
activities with international organizations or the industry
CFDA CCFDIE
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Division of Regulatory Authority
among Ministries
I. Food safety regulatory authority are
converging.
Main Regulatory Agency：5 2
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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
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CFDA CCFDIE Division of Regulatory Authority
among Ministries
III. Judicial linkage mechanism gradually
improved.
CFDA Ministry of Public
Security
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Division of Regulatory Authority
between CFDA and local FDA
Goal
upper and lower linkage
joint push pull
smooth operation
overall improvement
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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.
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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.
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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.
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Thanks for your Attention！
April 9, 2014
