The document discusses recent activities of Japan's Ministry of Health, Labour and Welfare (MHLW) regarding medical devices regulation. It outlines MHLW's action program to speed up medical device reviews through measures like increasing review staff and clarifying standards. The document also mentions MHLW's budget request for fiscal year 2012 to promote development of drugs and treatments, clinical research, approval reviews, and evaluation of new medical technologies.

1. Information on Japan
Regulatory Authority’s latest
activity for Medical Devices
2012
Sep, 2012
Japan Regulatory Service

2. Contents
MHLW’s Action Program to Speed up Medical
Device review
MHLW’s Budget Request for Medical Devices
FY2012
MHLW’s Medical Innovation Strategy
Revision of Pharmaceutical Affairs Law (PAL)

3. Action Program to Speed Up Medical
Device Review
The Japan's Ministry of Health, Labour and Welfare (MHLW) announced the action
program to speed up medical device review process in 2008. This action program is
based on MHLW's 5-Year Strategy for the Creation of Innovative Pharmaceuticals and
Medical Devices which was issued in 2007.
MHLW will take measures as below to provide safe and effective medical devices and
address new technologies rapidly.
1. Increase the number of review staff (35➜104) and improve the review quality.
2. Introduce 3-Track Review System
• 3-Track Review System
• Prior Assessment System for New Medical Devices
• Expand Consultation Service by PMDA
3. Clarify the Review Standard
• Clarify the Review Standard
• Set the review time system and Improve the progress management
4. Others
• Improve disclosure of information on PMDA’s website
• Approve all class II medical devices by the third party body
• Review the progress situation of this action program

4. Performance Goal for Review Time (Unit: month)
Actual FY2009 FY2010 FY2011 FY2012 FY201
Performance 3
Normal Total Review Time About 21 21 21 20 17 14
New Medical Devices
Authority side About 8 8 8 8 7 7
Applicant side About 14 14 14 12 10 7
Prior Total Review Time About 16 16 16 15 13 10
Authority side About 9 8 8 7 7 6
Applicant side About 9 9 9 8 6 4
With clinical Total Review Time About 16 16 16 14 12 10
Improvement Medical Devices
data
Authority side About 9 8 8 7 7 6
Applicant side About 7 7 7 6 5 4
Without Total Review Time About 11 11 11 10 9 6
clinical data
Authority side About 6 6 6 6 5 4
Applicant side About 5 5 5 5 4 2
Generic Medical Total Review Time About 8 8 6 5 4 4
Devices (With
approval Authority side About 5 5 4 4 3 3
standard)
Applicant side About 3 3 2 1 1 1

5. Working Group on Early Introduction of Medical
Devices with High Medical Needs
 Purpose
MHLW’s working group selects Medical Devices with high medical needs
among of them which has not been approved in Japan. They discuss
about Early introduction of them to hospital site.
 Main Topics
• Understand requests from academic circles etc.
• Assessment of clinical necessity including approval situation in
Western countries
• Measure for Early introduction
etc.

6. Current Status of Selected “Needs Articles”
(May. 31, 2012)
No. Article Public Under Under Under Approv
offering consider preparati review al
ation on
2 Carotid artery stent
5 Blood vessel
prosthesis for
reconstruction of right
ventricular outflow in
a child
10 Implantable holter
electrocardiograph
33 Salivary glands
endoscope
36 Full closed blood
extracorporeal
circulating device
Reference: http://www.mhlw.go.jp/stf/shingi/2r9852000002euw3-att/2r9852000002euxk.pdf

7. Contents
Action Program to Speed up Medical Device
review
MHLW’s Budget Request for Medical Devices
FY2012
MHLW’s Medical Innovation Strategy
Revision of Pharmaceutical Affairs Law (PAL)

8. Life Innovation Project for Health Care
Japanese government announced the Life Innovation Project to create innovative drugs and medical
devices in Japan with realize healthy longevity society. This project is based on the government’s New
Growth Strategy and Restructuring of Social-Security –Saxes, which aims contributing the economic
growth by strengthening the global competitiveness. The followings are the main contents.
• Cancer is the cause by which 1/3 of people dies in Japan. The development of a new medicine
for hepatitis B is also desired. Moreover, about regeneration medical treatment, the
reservation of safety, etc. are important issues, and it is supposed to research on the rejection
after a transplant. For this reason, MHLW supports the research costs for university hospitals
intensively about six items with high medical needs, such as cancer.
• It is necessary to pass through the procedure of "clinical trial" and "clinical study" which
validate the safety and the efficacy of new drugs etc. However, in the "clinical study"
performed by a doctor, the talented people including a clinical study coordinator is not
enough. For this reason, it is supposed to construct a "clinical study core hospital“ for
university hospitals etc. by supporting personnel expenses etc. .
• The product which utilized innovative technology is new technology, therefore, the guideline
what kind of examination should be carried out, and what kind of result to be safe, has not
been settled. If a guideline creates in parallel to research and development, early utilization is
attained as a result of effective development and quick examination. For this reason, the
research which evaluates the latest technical validity and safety in a university etc., personnel
exchanges with the organs are performed, and personnel training is planned. Moreover, a
guideline is created there to promote early utilization of regeneration medical treatment.

9. Life Innovation Project for Health Care
FY2012 budget request: about ¥12.7 bn
Task Measures
a. Promote development of drug a. Support for the research, the development, and the
discovery and treatment method utilization on individual important field (¥7.1 bn)
The distribution of Research cost for the • Cancer, hepatitis B, depression, refractory disease, scarcity disease
development of drug discovery and the • Regenerative medical techniques
treatment method with national needs is not • iPS cells
enough. • Construct Bio-bank for individualized medicine
b. Promote clinical research b. Support for the construction of core clinical trial hospital
In order to create innovative drugs etc. from
and strengthen the function (¥3.4 bn)
the result of abundant basic research in
• Select 5 new core clinical trial hospital and ensure staff supporting clinical
Japan, it needs to be base built with an
research
international level for performing clinical
• Arrange system of national highly-specialized hospital and support
study and tying to the approval based on
clinical research
high quality data.
c. Promote Approval review c. Improve the regulatory approval review system and the
It is required for development and approval safety measure corresponding to advance technology (¥2.1 bn)
reviews of innovative medical technology, For speeding up of the review corresponding to new technology, and improvement
such as regeneration medicine, to create the safety measures, grow the talented people who can evaluate the latest developing
evaluation guideline of validity, safety, and technical safety and validity, and share the results of research among of regulation
quality beforehand. side and development side by exchanging the talented people.
d. Evaluate new technology d. Research and Verification about the evaluation of new
Appropriately technology considering cost vs. effectiveness (¥0.08 bn)
The evaluation considering cost vs. The practicability at the time of carrying out medical economics evaluation
effectiveness is required about the experimentally by the rating system currently performed in foreign countries, etc.
reimbursement with evaluation of the are verified.
further innovation and secure the incentive Research and Verification of social influence, a guideline, etc. conducted based
of development for new medical technology. on a report of research etc.

10. Tsunami Disaster Reconstruction Support Project:
Innovative Medical Device Creation and Development
Promotion Project in Tohoku
FY2011 budget request: about ¥4.3 bn (5 years)
Purpose:
1. Creation of Innovative Medical Device, Attraction of enterprises and Creation of employment
2. Creation of opportunity that local residents can take the latest medical care.
Innovative Medical Device Creation and Financial Support for
Clinical trial etc.
Development Promotion Project in Tohoku
Relaxation of
Financial Support for Clinical Use of Innovative Medical Devices regulations
[Current situation] Iwate
Although a medical device used in foreign countries with high medical needs, it Tax breaks project
is not used in Japan. It is the main cause that the medical institutions which can request
fully perform medical device clinical trial have been lack.
[Overview of this project] Miyagi
Provide financial support to perform clinical trial by a doctor of innovative Focus on project
medical device in Tohoku, and conduct the progress management, consultation, research cost
and advisable support.
Promote the regulatory science research for early utilization of medical device. Fukushima
[Goal of this project] project
Dissolve “Unmet medical needs”, improve medical quality, and tie to
reconstruction in Tohoku by promoting exportation of innovative medical device
to Asian countries and expansion of employment.

11. Contents
Action Program to Speed up Medical Device
review
MHLW’s Budget Request for Medical Devices
MHLW’s Medical Innovation Strategy
Revision of Pharmaceutical Affairs Law (PAL)

12. Current Status and Problem on Medical
Innovation Strategy
• Medical needs have been changed according to the Japan’s population ages (Rapid increase of
cancer )
• More competitive globally according to technology progress
• Expansion of Japan’s trade loss of drugs and medical devices
Drugs→A decline in the ability to develop drugs
Medical Devices→Fail to utilize the advantages of Japan’s manufacturing ability
In the field of regeneration medical technique, individual medical treatment→Delay of practical
realization
Medical Innovation Strategy is necessary.
• Bring up medical industry as growing industry
• Provide the world’s highest grade medical care to Japanese
people
million yen million yen
Medical Devices Import/Export
Drugs Import/Export
Import Impor
t
Trade loss
Trade loss
(0.6 trillion
(1.2 trillion
yen)
yen)
Export Export
Reference: http://www.mhlw.go.jp/stf/shingi/2r9852000002b2wi.html

13. Contents
Action Program to Speed up Medical Device
review
MHLW’s Budget Request for Medical Devices
MHLW’s Medical Innovation Strategy
Revision of Pharmaceutical Affairs Law (PAL)

14. Revision of Pharmaceutical Affairs Law (PAL)
 History
• In light of drug-induced hepatitis, the task is that drug disaster will never
happen again.
• “Working group to discuss the future of drug regulatory authorities for
investigation of drug-induced hepatitis scandal and recurrence
prevention” was set up in May, 2008. (The members consist of chief of
bureaus invited by the Minister.) After the discussion for about 2 years,
“Final proposal” was summarized in April, 2010.
• “Final proposal” includes various contents. For example, set up the third-
party body that observes and evaluates drug regulatory authority to
prevent occurrence and expansion of drug-induced disease.
• On the other hand, revision matters of PAL had been discussed at
Working Group who discusses the revision of PAL since May 22, 2011, and
they were summarized in January 2012.

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