japanese regulations and jsqa update - amazon s3€¦ · gqp/gvp/gpsp division: 208 members from 84...

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

11/11/2016International Affairs Committee / JSQA4

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

11/11/2016International Affairs Committee / JSQA

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）


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)


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


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


GQP/GVP/GPSP Division

15%



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.




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.


Expectations of new

collaborations between RQA and

JSQA


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


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


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