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REGULATORY REQUIREMENT IN
J APAN AND CHINA 1
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REGULATORY AUTHORITY
Japanese Ministry of
Health, Labor, and Welfare
(MHLW)
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The Pharmaceuti- cals and Medical Devices Evaluation
Center (PMDEC), usually known as ´The Center,µ is the actual
decision- maker for approval of new drug applications (NDAs).
The Organization for Pharmaceutical Safety and Research
(OPSR), also known as ´Kikoµ or ´the DOµ (Drug
Organization), is an independent body, related to the
MHLW, that is in charge of discussing drug development
programs with industry.
A merger of these two organiza- tions has been announced in the
past few years, and would result in the creation of an equivalent
to the American FDA.
The three aforementioned organizations are involved in
approval reviews
The regulatory body and ultimate decision-maker is the MHLW .
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Pharmaceutical regulatory authority of Japan is
the Pharmaceutical and Food Safety Bureau
(PFSB) of the MHLW
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A REVOLUTION IN J A P AN
The implementation in Japan in 1997 of the GCP guide- line
ICH E6
Guideline ICH E5, the ethnicity guideline
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A REVOLUTION IN J A P AN
The implementation in Japan in 1997 of the GCP
guide- line ICH E6, known in Japan as ´the new
GCPµ
y ICH E6 was published in three separate
documents
y
An English translation of the Japanese GCP isavailable
y new written informed consent 14
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In 1997 the new GCP regulations allowed the CROs to
take over responsibility of phase 2 and 3
In hospitals involved in phase 2 and 3 clinicaltrials, SMOs now assume the training of
physicians and nurses, setup of clinical trial centers,
staffing with the CRCs, writing of standard operating
procedures (SOPs), and interaction with monitors or
auditors from the regulatory authority
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THE CONCEPT OF ETHNIC BRIDGING
Guideline ICH E5, the ethnicity guideline
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A IM OF ICH E5
To reduce duplication of clinical studies by setting up a
process for evaluating the possibility of extrapolating
clinical data from one regulatory area to another.
Successful in reducing the
necessity to reproduce clinical research programs in
Japan for drugs that have already been approved in the
West.
The guideline describes in detail which drugs may be
more easily ´bridgedµ from one area to the other17
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Additional information regarding the phar-
macokinetics of the drug in the new populati
on is needed.
design a comparative trial involving bothJapanese and Western
subjects in one protocol.
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F ACTORS (ICH E5)
ICH E5 defines two types of ethnic factors that
may have an influence on drug development
y
Intrinsic factors are genetic and related to the actualhuman population of the regulatory area.
y Extrinsic factors are related to the culture of the
area.
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NDA REVIEW PROCESSES AND TIMELINES -1-
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PAC
Additional route, indication,
formulation, doseNMEAdditional spec,
manufacture*
DO
Secretariat
Review
Review Review
Review Report
Report
MHLW Approval ApprovalApproval Approval
Expert Review ReviewReviewReview
1 ± 2 m
1 ± 2 m 0.5 ± 1 m
1 m
1 m
Team Review
PMDA
MHLW
*not conduct clinical trial
9 ± 11 m3 m
NDA
? m
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NDA SUBMISSION REQUIREMENTS
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DIAGRAMMATIC REQUIREMENTS OF THE ORGANIZATION OF
THE ICH CTD
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Module 2
M 1
Regional
Administrative
Information
M 2.3
Quality
Overall
Summary
M 2.4
Nonclinical
Overview
M 2.5
Clinical
Overview
M 2.6
NonclinicalWritten&Tabul.
Summaries
M 2.7
ClinicalSummary
M 3
Quality
M 4
Nonclinical
Study Reports
M 5
Clinical Study
Report
Not part of the CTD
CTD
M 2.1 CTD ToC
M 2.2 Introduction
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HISTORY BACKGROUND
In 1998, State Drug Administration established;
± SDA oversees all drug manufacturing, trade, andregistration.
In 2003, the SDA was restructured to becomethe State Food and Drug Administration(SFDA)
In 2003, Newly added functions-Drugs (Including Chinese Crude Drugs, Processed
Slices of TCMs, TCMs, A PIs, Chemicals, Antibiotics,Biochemicals, Radiopharmaceuticals, Vaccines, etc.)
-Medical Devices
-Food, Cosmetics, Health Food 27
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Establishment of a single drug regulatoryauthority
It eliminated the conflicting standards
that prevailed among provincialgovernment agencies
Centralized the Chinese healthcare
regulatory system
More transparent.28
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SFDA :new regulations follow FDA's model.
SFDA required all pharmaceutical companies in
China to obtain GMP certificates from SFDA by
June 30, 2004 to be licensed to sell their drug
products in China
In 2005, SFDA launched a regulation on drug
research and supervision management aimed at
enforcing GLP to investigative drugs, traditional
Chinese medicine injections and biotechnology
products.
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China is following and copying U.S. rules.
National regulation is implemented by SFDA and
other state agencies, while local regulation isimplemented by provincial agencies.
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the SFDA was formerly an autonomous
regulatory agency, it has now been put under the
direct command of the Ministry of Health (MOH)
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US FDA IN CHINA
important development in late 2008
establishment of US FDA offices in China
Open in Beijing, Shanghai, and Guangzhou.
These offices were conceived in response toshortfalls in the FDA·s inspection of overseas
manufacturers.
In particular, in the wake of American
deaths from tainted Chinese heparin, itwas discovered that the heparin·s
Chinese manufacturer had never been
inspected despite having FDA approval.32
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A BOUT SFDA
State Food and Drug Administration (SFDA)
founded in 2003, directly led by the State Council
of P. R. China;
Local Agencies: 31 provincial-, 433 municipality-
,1,936 county- level agencies (2,401 total);
Technical Organizations: 16 state-, 122
provincial-, 373 municipality-, 436 county- level
organizations (947 total)
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SFDA IS :
In charge of administrative supervision and
technical supervision over the research,
production, distribution and use of drugs
and medical devices.
Drugs :
including Chinese crude drugs, prepared slices of
Chinese crude drugs, traditional Chinese
medicine preparations, chemical drug substances
and their preparations, antibiotics, biochemical
drugs, radioactive pharmaceuticals, serum,
vaccines, blood products and diagnostic agents 34
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China has established drug regulatory
departments under the unified leadership of the
central government, with vertical management
below the provincial level.
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By the end of 2007,
2,692 drug regulatory departments in China,
including
y 31 at the provincial level,
y 339 at the municipal (prefecture) level
y 2,321 at the county (county-level city)level (including districts and counties of municipalities directly under the centralgovernment);
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More than 1,000 drug technical supervision
organizations with 64,000 personnel in China.
Rural areas, drug safety coordinators andinformation specialists had been employed to
ensure drug safety and promote the building of a
drug safety supervision network.
A total of 578,000 stations of rural drug
regulatory network had been established.
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State Council
SFDA
Gener
al
Office
Dept. of
Drug
Registra
tion
Dept. of
Drug
Market
Compliance
Dept. of
Drug
Safety
&Inspection
Dept. of
Medical
Devices
Dept. of
Personne
l &
Education
Dept. of
Internati
onal
Cooperation
Dept. of
Policy &
Regulatio
n
Dept. of
Food
Safety
Supervision
Dept. of
Food
Safety
Coordination
Organizational Structure of SFDA
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FUNCTION
Develop policies and programs ,supervise theirimplementation; participate in drafting relevantlaws, regulations and normative documents;
Develop good practices ,supervises theirimplemantation
Incharge of hygiene licencing and safetysupervision of health food
Is in charge of administrative and technicalsupervision of drugs and medical devices.
Draw up relevant national standards of drugs and
medical devices, and supervise their implementation Carry out the Adverse Drug Reaction (ADR)
monitoring ,organize the implementation of classification system for prescription drugs andOTC drugs; 39
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Charge of formulating regulations of
Traditional Chinese Medicines (TCMs) and
supervise their implementation
Supervise the quality and safety of drugsand medical devices
To organize the investigation and
punishment of illegal activities
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FUNCTIONS«..
To direct relevant local work regarding food
and drug administration, emergency response,
inspection and informationalization;
To draw up and improve qualification systemfor licensed pharmacist, direct and supervise the
registration of licensed pharmacist;
To carry out international exchanges and
cooperation related to food and drug regulation;
To undertake other work assigned by the State
Council and the Ministry of Health.
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N ATIONAL-LEVEL DRUG TECHNICAL
SUPERVISION ORGANIZATIONS
National institute of the control of pharmaceutical
and biological products (NICPBP)
Chinese pharmacopoeia commission (CPC)
Center for drug evaluation (CDE)
Center for certification of drugs (GMP Inspection)
(CCD)
Center for drug reevaluation (Postmarketing) (CDR)
National committee on the assessment of the
protected traditional Chinese medicinal products(NCA PTCMP)
Center for medical device evaluation (CMDE)
Other centers and associations 42
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These organizations, all affiliated to SFDA, take
the responsibility of
y routine testing,
y testing methodology research,
y conservation of breeds of experimental animals,
y standardization research,
y technical evaluation of registration applications and
ADR monitoring.
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Thank you for your attention!