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Japanese regulations
and JSQA update
Tadahiro Yoshiyama
International Affairs Committee
Director of GLP Division
November 11, 2016
Contents
Japanese regulatory updates of the
GxP systems
Recent activities in JSQA
Expectations of new collaborations
between RQA and JSQA
11/11/2016International Affairs Committee / JSQA 2
Japanese regulatory updates
of the GxP systems
11/11/2016International Affairs Committee / JSQA3
Summary
The inspection methods and
perspectives of the Japanese
regulatory authority may be
changed
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Over the past year, a partial revision and
expansion of the evaluation scope
occurred in the Japanese GxP systems
Expansion of the GLP evaluation scope
1. Coming into effect in GLP ordinance for
cellular and tissue based products➣ Ministerial Ordinance on Good Laboratory Practice
for Non Clinical Safety Studies of Cellular and Tissue
Based Products
(Ordinance of the Ministry of Health and Welfare
No. 88 of July 30, 2014)
2. Start of the facility inspection by PMDA and
inspection of 8 facilities has already been
carried out
JSQA started collection and analysis of the
information about the inspection by PMDA
in GLP subcommittee
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5
Securing of quality of Electric
Record& Signature
Scope
Life Cycle
System
Inventory
Risk Assessment
Periodic
Review
Personnel
Up-to-date listing of all
GLP-relevant systems
Validation activity of the
appropriate frequency
according to a risk
assessment results
Responsibility of the Facility
Management newly recognized
Importance of the
participation of Study
director, IT person and
system vendor
Validation strategy based on
potential risks to data integrity
Impact in the CSV activity in Japan
Coming into effect in New OECD Advisory
Document on GLP computerized system
OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE
AND COMPLIANCE MONITORING Number 17
International Affairs Committee / JSQA 6
Japanese Good Clinical Practice (J-GCP) was partially
revised this year, because the inclusion of J-CU.
“the partial revision of J-GCP for Drugs” MHLW
Ministerial Ordinance No.9 became effective from
Jan 22, 2016.
“the partial revision of J-GCP for Medical Devices”
MHLW Ministerial Ordinance No.128 became effective
from Jul 21, 2016.
“the partial revision of J-GCP for Regenerative
Medicines” MHLW Ministerial Ordinance No.129
became effective from Jul 21, 2016.
J-CU applications
3 protocols were published. (As of 30 Sep., 2016)
11/11/2016International Affairs Committee / JSQA
Japanese Compassionate Use (J-CU)
has begun at last
7
Revision of the recent GVP-related law
Revision of the Pharmaceutical Affairs Law
(November 27, 2013)
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8
GVP-related laws were revised(July 30, 2014)
• GVP ordinance Cellular and tissue based products were increased as an
object of post-marketing safety management operations
• Pharmaceutical Affairs Law Enforcement
Regulation
About the entrustment of post-marketing safety
management operations, Re-entrustment was accepted,
under the constant condition
Summery of Revision
Recent GVP In-compliances In one company, advance reaction was not reported within the periodby system failure.
• Medicinal Product : 5475 cases (57 ingredients)
• Investigational Products: 154 cases (28 ingredients)
Correspondence of the MHLW
• To One company which violated
• Business Suspension Order :15 days
• Business Improvement Order : Twice
• To Representatives of first-class Pharmaceutical marketing
authorization holders (271 Companies)
• Requested to do Voluntary Self-Inspection about the in-
house GVP systems
Result
• In 20 companies, the defects of the procedure were
found out
• In 6 companies, Advance reaction information unreported
(88 cases in total 133 examples)
Recent activities in JSQA
Making of medium and long term administration
policies, covering the next 5 years
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Making of medium and long term
administration policies and schedules
JSQA set the policies and plans for our activities
in line with the change in environment
Structure of Members (As of 31 Aug., 2016)
GLP Division 37%
GCP Division 48%
1366 members from 426 companies
GLP Division: 496 members from 155 companies
GCP Division: 662 members from 187 companies
GQP/GVP/GPSP Division: 208 members from 84 companies
11/11/2016International Affairs Committee / JSQA 11
GQP/GVP/GPSP Division
15%
Making of medium and long term
administration policies and schedules
Policies and schedules aim at getting the following
results in five years
Announcement of the outcome of the selected
study
Completion of the educational training system
& establishment of the QA authorization
• Publication of the activity result by methods such as a
presentation at the meeting or the article contribution.
• Collection of outside evaluations about activities and referring
them to the next problem setting meeting.
• Establishment of the QA authorization in each GxP system.
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Making of medium and long term
administration policies and schedules
Policies and schedules aim at getting the following
results in five years
The strengthening of the liaison between
external/internal related associations and regulatory
authorities
Arrangement of operations and systems,
leading to activation
• Collaboration with external/internal related associates and
regulatory authorities.
• Further cooperation between RQA, SQA and JSQA, about 5th
and 6th GQAC.
• Increase the number of members engaged in the GQP/GMP/
GDP, Medical device or QMS.
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Expectations of new
collaborations between RQA and
JSQA
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Effective use of collaborations
The making of deliverables
through collaborationsThe employment of
RQA training materials
for JSQA personnel
The holding of
periodical meetings
about an discussion
items
JSQA is expecting further collaborations with RQA, on
various topics
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Autumn Scenes in Japan
JSQA will support the 5th
GQAC.So, through
cooperation and
information sharing, let's
make this event a success.11/11/20
16International Affairs Committee / JSQA 16
The deliverables which come from the material of the
collaboration.
Effective use of collaborations
11/11/2016
International Affairs Committee / JSQA
17
Activity Summary of 12th Term(2014-2015)
- GLP Division
- GCP Division
- GQP/GVP/GPSP Division
- Common Special Project 1, 2
Activity Summary of 11th Term(2012-2013)
- GLP Division
- GCP Division
- Common Special Project 1, 2
http://www.jsqa.com/en/index.html
Thank you
ありがとうございました
11/11/2016International Affairs Committee / JSQA 18
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