Transcript Main Contents

Introduce GLP/GCP into
China
Shixin XU, PhD, Prof.
China IVDC
I.
II.
III.
IV.
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The Benefits of GLP/GCP
Main contents of GLP/GCP
Progress of GLP/GCP
Target of GLP/GCP
I. VICH
The Benefits of GLP/GCP
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Benefits
• to avoid the waste on repeated study in the
development of veterinary drug
• ensure the conduct of test (genuine)
• improve the quality of data (integrity)
• ensure the validity of test data (reliability)
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Benefits
• prevent the application dossier may have the
following problem:
study protocol is irrational
test animal standards are not fulfilled
animal facilities do not fulfill the requirement
 test results are inexplicable
 operation procedures are not normative
 false data-veracity
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II. VICH
Main contents of GLP/GCP
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Main Contents
•
GLP in China

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8 chapters, 48 articles, including
a)
General rules
b)
Institutions and personnel
c)
Test facilities
d)
Instruments and materials
e)
SOPs
f)
Enforcement of test
g)
Archives
h)
Annex
Main Contents
• GLP applicable to non-clinical studies related to acute toxicity,
subchronic toxicity, reproductive toxicity(teratology study),
chronic toxicity (carcinogenic test), and immunogenic test, local
toxicity and irritation test, toxicokinetics, etc., other test
available for the safety assessment within laboratory.
• Similar to human medicine GLP, or OECD GLP guidelines.
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Main Contents
• GCP in China
14 chapters, 74 articles,
including
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h) Data management
and statistical analysis
i) Enforcement of test
a)
General rules
b)
Institutions and personnel
c)
Sponsor
d)
Monitor
k) Animal Selection and
management
e)
Preparation and
requirement
l) Quality assurance and
control
f)
Test Protocol
m) Multicenter test
g)
Records and report
n) Annex
j) Administration on
investigational drug
Main Contents
• GCP applicable to clinical studies related to various
systemic studies on target animals.
• Similar to VICH GCP guidelines.
• only frame of the guidelines was modified, ideas are
embodied in Chinese GCP. Responsibility of investigator,
sponsor and monitor, documentation and report, animal
welfare and disposal are stipulated.
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Main Contents
• Institutions for clinical trials
Seems to be the third independent institution
mandatory to be juridical institution, have the required
laboratory and animal farm related to test titles conducted,
the animal facilities and equipment and laboratory
instrument could meet the requirement to safely and
effectively conduct the clinical study.
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Main Contents
• certificate and compliance
• The institution can voluntarily apply for certification, but
will accept regular and irregular audit.
• to be based on the animal species, test titles and type of
drug (medicine, vaccine, herb medicine). i.e.,
 Pharmacokinetics of medicine in pigs
Clinical trials of antiparasitics in cattle
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Main Contents
• considerations
 different test titles, need different test instrument
 different animal species, need different animal facilities,
husbandry management and environment
 clinical trials may be termed as artificial infectious animal
and natural infectious animal.
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III. VICH
Progress of GLP/GCP
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Progress
• Currently, GLP/GCP guidelines have not yet been
officially issued, but public comments in China have
been finished, many company including foreign
industry had presented their comments to MOA.
• It is estimated to be issued in 2015, and will be
enforced in the year.
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Progress
• The equivalence between laboratory accreditation
system or metric accreditation and GLP/GCP?
• Professional personnel and animal facilities may be
more important in GLP/GCP
• Standard Operation Procedures for animal test need
to established
• Animal facilities need to be improved further
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Progress
• Several Challenges
the institution has not yet handled the GLP/GCP
guidelines, including our IVDC, though we
participating the discussion of the draft.
The team of accreditation and compliance has not
yet been setup, and members of the team need to
be trained and further to study the official
guideline.
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IV. VICH
The target
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Target
• GLP
 From the point of view on toxicology evaluation for veterinary
medicines, GLP laboratory from human drugs can be accepted
directly.
 There are 43 labs for human drugs have been certificated
including labs from the third independent labs, regulatory labs
and industry labs.
 Several tests like PK, BE, residue depletion may follow both GLP
and GCP.
 For veterinary drugs, 10 GLP Labs may be expected
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Target
• GCP
The most needed guidelines for clinical trials
The more labs, the better, sponsor can have more
selection right.
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Target
• Industry labs certificate
The labs from industry may have same rights as
the third independent labs.
Industry labs can provide test results only for its
own application of registration for products.
Foreign industry will be equal treated as internal
industry, no discrimination.
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China MOA public website
http://www.moa.gov.cn
China IVDC public website
http://www.ivdc.gov.cn
http://www.ivdc.org.cn
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Thank you for your attention!
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