JMO Annual Report - MedDRA

JMO Annual Report

Fiscal 2008

(April 1, 2008 ~ March 31, 2009)

Japanese Maintenance Organization
Society of Japanese Pharmacopoeia

June, 2009

Introduction

This report covers JMO (Japanese Maintenance Organization) related activities in the
fiscal year 2008

Two JMB(Japanese Management Board) Meetings were held during this period.

The 31st JMB meeting was held on 24 July 2008.
Agenda
1. Report of JMO activities and financial result in 2007
2. Action plan and financial plan of JMO in 2008
Both were approved by JMB

The 32nd JMB meeting was held on 4 November 2008.
Agenda
1. Pre-meeting for MB meeting in Brussels
2. Approval of JMO report from 1 April 2008 to 30 September 2008
3. Provision of MedDRA Chinese version for JMO subscribers

I State of Subscription

The number of MedDRA/J subscribers is 495 including 341 pharmaceutical companies
(71 web subscribers included) at the end of March 2009.
Total number of subscribers increased from 483 to 495 compared to the end of
September 2008.

The breakdown of subscription is as follows:

Subscriber type Business type (As of 31 March 2009)
Number of subscribers

JMO Core Pharmaceutical 270
CRO 23
Hospital 17
Educational 4
Non profit 11
Other 53

Academia Academia 13

Web Pharmaceutical Pharmaceutical 71

Web Academia Academia 18

Regulator 15

Total 495

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Web Academia Regulators 15
18

Web 71

Academia 13 Ph armaceuticals
270
Others 53

Non-profit 11 CRO 23

Academias 4

Medical inst. 17

II Services provided for subscribers

1) MedDRA/J Releases
Version 11.1 (September 2008)
Version 12.0 (March 2009)

2) Change Requests

JMO processed 93 change requests from MedDRA/J subscribers and additional 81
developmental changes originated from JMO itself. Within these 93 change requests, 14
requests were modification of Japanese translation. Finally, 145 requests were
submitted to MSSO and 87 were accepted by MSSO and included in version 12.0 of
MedDRA.
JMO has participated in the MSSO’s International Medical Review and responded to
2,861 terms assigned by MSSO. Within these 2,861 terms, 1,536 terms are not eligible
for Japanese translation since they were rejected or placement changes to existing
terms. Finally, 1,592 (including 214 SMQ related requests) were accepted and 125
requests were suspended for further evaluation.
Within the accepted change requests, newly added 929 terms are translated into
Japanese.

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3) Help Desk
There were 202 inquiries from JMO subscribers and settled.
The majority of questions were
What is the best term selection for a specific reported term
How to access JMO Website
How to use JMO browsers

4) User Group Meetings

Two meetings were held in Tokyo and Osaka
On28 November in Osaka, 59 participants from 33 organizations
On 4 December in Tokyo, 122 participants from 72 organizations
Agenda were
Recent status of drug safety measures and MedDRA/J--------------------------MHLW
Practical use of MedDRA/J in PMDA --------------------------------------------------PMDA
Recent status of MedDRA/J usage and challenges in Pharmaceutical companies

---------------------------3 Pharmaceutical companies
Activity report from JMO---------------------------------------------------------------------JMO

5) Explanatory Meetings for the New Version

Two meetings were held in Tokyo and Osaka for Version 11.1
On 30 September 2008 in Tokyo 138 attendees from 84organizations
On 03 October 2008 in Osaka 66 attendees from 42 organizations
For version 12.0 ( for reference)
On 06 April 2009 in Osaka 87 attendees from 42 organizations
On 09 April 2009 in Tokyo 195 attendees from 95 organizations

6) Trainings for MedDRA/J users

Six training courses were held in Osaka and Tokyo.

Essential course
11 June 2008 in Tokyo, 93 trainees from 41 organizations
30 June 2008 in Osaka 45 trainees from 37 organizations
14 October 2008 in Tokyo, 45 trainees from 29 organizations
Coding course
08 July 2008 in Tokyo, 46 trainees from 32 organizations
18 July 2008 in Osaka 28 trainees from 14 organizations
11 December 2008 in Tokyo, 36 trainees from 18 organizations

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Open seminar free of tuition)
17 July 2008 in Osaka, 84 attendees from 47 organizations
05 November 2008 in Tokyo, 103 attendees from 67 organizations
11 March 2009 in Tokyo 125 attendees from 68 organizations
Substantial number of attendees suggested potential MedDRA/J subscribers.

SMQ seminar
24 October 2008 in Osaka, 35 trainees from 21 organizations
28 October 2008 in Tokyo 90 trainees from 50 organizations

7) Renewal of MedDRA/J browsers
No action was taken during this period.

8) MedDRA/J Task force
A task force consisting of MedDRA/J subscribers has been working since 2004 for
the purpose of enhancing practical and standardized use of MedDRA/J.
The task force is managed by MedDRA/J subscribers themselves and JMO is
providing back-up as a secretariat.

During this period, three Taskforce meetings were held.

22 May 2008 a general task force meeting was held
A draft of “Revision of MedDRA Term selection Points to Consider with Japanese
guide for optimum use of MedDRA/J” was distributed beforehand by JMO and what
items should be included in the next version.
29 August 2008 a general task force meeting was held
Topics discussed were

1. Report on ICH meeting in Portland
1-1 Addition of explanation about usage of SMQs in Data Retrieval and

Presentation PTC
1-2 Revision of Term Selection PTC

2. Recent MedDRA related topics
2-1 Release schedule of MedDRA 11.1
2-2 Chinese version of MedDRA
2-3 CTCAE project
2-4 DIA meeting in USA

27 February 2009 a general task force meeting was held
A draft of “Revision of MedDRA Term selection Points to Consider Release

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3.12with Japanese translation was distributed by JMO and what items should
be added in the next version and revision of Japanese guide for optimum use of
MedDRA/J” were discussed.
Topics discussed were
1. Report on ICH meeting held in November in Brussels
1-1 Addition of explanation about usage of SMQs in Data Retrieval and

Presentation PTC
1-2 Revision of Term Selection PTC
2. Recent MedDRA related topics
2 -1 Chinese version of MedDRA
2 -2 CTCAE project
3. Release schedule of MedDRA V.12.0

Summary

The JMB members from MHLW were changed twice during this period.

Mr. Nobuhiro Yamamoto replaced Dr. Tetsuya Kusakabe as of 07 July 2008, and then
Mr. Yoshihiko Sano replaced Mr. Nobuhiro Yamamoto as of 01 January 2009.

The number of subscribers in total increased from 473 to 495 compared to previous year,
but number of Core Pharmaceutical companies were decreased from 274 to 270. The
main factor of the decrease was transfer of registration from core service to Web only service
in some of small revenue Pharmaceutical companies.

JMO has been addressing to improve services to MedDRA/J users such as user

trainings, open seminars or SMQ seminars.

Participation of substantial number of subscribers in every Explanatory Meetings for the
New Version shows high interest of subscribers in the up-dated information.

The number of change request from JMO subscribers seemed to be stabilized at
around100 requests (including modification of Japanese translation) per year.

The activity of MedDRA/J Task force seems to be very helpful for MedDRA/J users to
understand MedDRA related documents such as PTC documents, CTC AE and SMQs.
and reflect their opinions to further revision of the PTC documents.
Interest in SMQs is increasing among MedDRA/J subscribers but it will take more time
for actual implementation of SMQs.

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