Information on Japan Regulatory Authority’s latest activity for Medical Devices 2012

Sep, 2012 Japan Regulatory Service

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)

Action Program to Speed Up Medical Device Review

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

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.

Actual Performance

FY2009 FY2010 FY2011 FY2012 FY2013

New

Med

ical Devices

Normal Total Review Time About 21 21 21 20 17 14 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

Imp

rovemen

t Med

ical Devices

With clinical data

Total Review Time About 16 16 16 14 12 10 Authority side About 9 8 8 7 7 6 Applicant side About 7 7 7 6 5 4

Without clinical data

Total Review Time About 11 11 11 10 9 6 Authority side About 6 6 6 6 5 4 Applicant side About 5 5 5 5 4 2

Generic Medical Devices (With

approval standard)

Total Review Time About 8 8 6 5 4 4 Authority side About 5 5 4 4 3 3 Applicant side About 3 3 2 1 1 1

Performance Goal for Review Time (Unit: month)

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.

Working Group on Early Introduction of Medical Devices with High Medical Needs

Current Status of Selected “Needs Articles” (May. 31, 2012)

No. Article Public offering

Under consider

ation

Under preparati

on

Under review

Approval

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

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)

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.

Life Innovation Project for Health Care FY2012 budget request: about ¥12.7 bn

Task Measures a. Promote development of drug discovery and treatment method The distribution of Research cost for the development of drug discovery and the treatment method with national needs is not enough.

b. Promote clinical research In order to create innovative drugs etc. from the result of abundant basic research in Japan, it needs to be base built with an international level for performing clinical study and tying to the approval based on high quality data.

c. Promote Approval review It is required for development and approval reviews of innovative medical technology, such as regeneration medicine, to create the evaluation guideline of validity, safety, and quality beforehand.

d. Evaluate new technology Appropriately The evaluation considering cost vs. effectiveness is required about the reimbursement with evaluation of the further innovation and secure the incentive of development for new medical technology.

a. Support for the research, the development, and the utilization on individual important field (¥7.1 bn) • Cancer, hepatitis B, depression, refractory disease, scarcity disease • Regenerative medical techniques • iPS cells • Construct Bio-bank for individualized medicine

b. Support for the construction of core clinical trial hospital and strengthen the function (¥3.4 bn) • Select 5 new core clinical trial hospital and ensure staff supporting clinical

research • Arrange system of national highly-specialized hospital and support

clinical research

c. Improve the regulatory approval review system and the safety measure corresponding to advance technology (¥2.1 bn) For speeding up of the review corresponding to new technology, and improvement safety measures, grow the talented people who can evaluate the latest developing technical safety and validity, and share the results of research among of regulation side and development side by exchanging the talented people.

d. Research and Verification about the evaluation of new technology considering cost vs. effectiveness (¥0.08 bn) The practicability at the time of carrying out medical economics evaluation experimentally by the rating system currently performed in foreign countries, etc. are verified. Research and Verification of social influence, a guideline, etc. conducted based on a report of research etc.

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.

Iwate project

Miyagi project

Fukushima project

Financial Support for Clinical trial etc.

Relaxation of regulations

Tax breaks request

Focus on research cost

[Current situation] Although a medical device used in foreign countries with high medical needs, it is not used in Japan. It is the main cause that the medical institutions which can fully perform medical device clinical trial have been lack. [Overview of this project] Provide financial support to perform clinical trial by a doctor of innovative medical device in Tohoku, and conduct the progress management, consultation, and advisable support. Promote the regulatory science research for early utilization of medical device. [Goal of this 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.

Innovative Medical Device Creation and Development Promotion Project in Tohoku

Financial Support for Clinical Use of Innovative Medical Devices

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)

million yen million yen

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

Drugs Import/Export Medical Devices Import/Export

Import

Export

Import

Export

Trade loss (1.2 trillion

yen)

Trade loss (0.6 trillion

yen)

Reference: http://www.mhlw.go.jp/stf/shingi/2r9852000002b2wi.html

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)

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.

Revision of Pharmaceutical Affairs Law (PAL)

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