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Japan's device lag could be a thing of the past

This article was originally published in Clinica

Executive Summary

Japan has come under fire from industry for its slow approvals system for medical devices compared to that of the US. But, as Junko Kodama, chairman of the regulatory affairs and quality assurance (RAQA) committee at the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD), explains, “momentous changes” are underway to change the system for the better.

Currently, approximately half of the medical devices available in the US and the EU are not available in Japan.

Junko Kodama, chairman of the regulatory affairs and quality assurance (RAQA) committee at the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)

This unfairly denies Japanese patients access to the best technology currently available. Medical devices and diagnostics critical in the diagnosis and effective treatment of diseases should be available to patients all over the world.

For various reasons, however, there are great differences in access to medical devices even among industrialised countries. The delay in providing medical devices in Japan compared with access to the same devices in Europe and the US is referred to as the device lag.

The tables below show the difference in the total review period between Japan and the US for new medical devices and in-vitro diagnostics (PMA-equivalent products) and others (510(k)-equivalent products) which were approved in Japan between 2006 and 2008 (Fig.1 and Fig. 2).

Figure 1. Changes in the review period for PMA-equivalent products
Fusionchart: Salina Christmas

Fig. 2. Changes in the review period for 510(k)-equivalent products

Figure 2. Changes in the review period for 510(k)-equivalent products
Fusionchart: Salina Christmas

* n = Number of products approved

Source: “2008 Device Lag Study” by the American Chamber of Commerce in Japan (ACCJ)

While Japan’s review period is improving; a significant lag remains. The average total review period for medical devices and in-vitro diagnostics for PMA-equivalent products in the US between 2006 and 2008 was 10.1 months, while it was 21.1 months in Japan. In addition, the review period for 510(k)-equivalent products was 14.3 months in Japan, while it was only 2.2 months in the US.

In an effort to eliminate the device lag, the Ministry of Health, Labour and Welfare (MHLW) announced an action programme to accelerate the approval process of medical devices (excluding IVDs) on December 11, 2008. The plan aims to speed up the system by:

  • improving the efficiency of the review processes by increasing the number of reviewers, and improving their training

  • adopting a three-track review system for ‘new’, ‘improved’ and ‘me-too’ medical devices

  • setting performance goals

The number of reviewers will gradually increase from 35 (as of March 2009) to 104 by 2013 (although review fees were increased in April 2009).

In April this year, I was invited by the Pharmaceuticals and Medical Devices Agency (PMDA) to present at a training seminar for 140 new employees including eleven new reviewers. I was able to see first-hand that a momentous change is on the horizon and I have high hopes that the training programme will fulfill its function to reduce inconsistencies among review categories and reviewers.

The adoption of a three-track review system is expected to go a long way in shortening the review period. The single track system reviewed ‘new’, ‘improved’ and ‘me-too’ medical devices together and it was suggested that this was one factor contributing to the device lag.

In 2008, the American Chamber of Commerce in Japan (ACCJ) and the US medical technology association, AdvaMed, submitted recommendations to the MHLW regarding methods to improve the review system.

The recommendations included ‘least burdensome approach’, an approach adopted by the US, in which both the reviewer side and applicant side must use whatever reasonable means available to reduce the review period while ensuring the safety and effectiveness of the medical product being evaluated. The recommendations were subsequently accepted.

Establishing performance goals for the review process (see Table 1 below) was the most remarkable development. This is the most significant achievement in 24 years since the standard review period for new medical devices was set to one year, after the US – Japan MOSS (market-oriented sector selective) negotiations in 1985.

Table 1: Target review periods (median approval cohort), in months

 

Actual

 

FY 2009

 

FY 2010

 

FY 2011

 

FY 2012

 

FY 2013

 

New Device

 

Normal

 

Approx. 21

 

21

 

21

 

20

 

17

 

14

 

Priority

 

Approx. 16

 

16

 

16

 

15

 

13

 

10

 

Improved Device

 

Clinical trials

 

Approx. 16

 

16

 

16

 

14

 

12

 

10

 

Without clinical trials

 

Approx. 11

 

11

 

11

 

10

 

9

 

6

 

Me-too device (with approval standards)

 

Approx. 8

 

8

 

6

 

5

 

4

 

4

 

(Unit: months)

The government and the medical device industry have agreed to track the progress of the action programme on a regular basis, starting this Autumn. Achieving these performance goals will not be easy. This is, however, the beginning of a cooperative effort between the government and the medical device industry to achieve the common objective of delivering superior medical devices to patients in Japan without delay.

For further details about the AMDD, go to http://www.amdd.jp/en.

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