Japan’s Efforts For ‘Zero’ Device Lag To Guide EU?

Japan aims to achieve “zero” review lag for medical devices by introducing new measures for products coming into the system and taking action to speed up reviews of devices already underway. It is taking a different approach according to how urgent the review is, or how urgently the product is needed.

In Japan, the Pharmaceuticals and Medical Devices Agency is aiming to cut the time it takes to review medical device applications for priority review products to 10 months for 80% of products by fiscal year 2018 (ending March 2019) and to 14 months for standard review products in 80% of cases.

But already it is showing that it is well ahead of its targets, as is demonstrated in its Annual Report for FY2014.

Speed of product review is a critical issue for manufacturers the world over. With a reduction in the number of EU notified bodies still ongoing and new Regulations soon to be adopted in the EU which threaten to create backlogs for product reviews at the notified bodies, the Japanese example may provide some food for thought for the EU.

Part of this initiative has involved analyzing reasons for outstanding prolonged review and resolving ongoing relevant issues for each product and clearing the backlog.

Moreover, to eliminate review/development lag for medical devices being developed or to be developed in the near future, PMDA is encouraging medical device-related industries, medical device companies, and academic institutions to take measures such as the proactive use of clinical trial consultations prior to regulatory submission to speed the process along.

The authority says it has made use of various meetings to provide specific examples of deficiencies often seen at the time of application and to call for improvements in applicant submissions.

Five Categories

In terms of aiming to prioritize as well as achieve its targets, the authority has broken down devices into five main categories as follows: priority review products; standard review products; improved medical devices with clinical data; improved medical devices without clinical data; and generic medical devices

Priority reviews are conducted for applications for orphan medical devices and other devices that are regarded as having particularly high medical need (medical devices for serious diseases and with distinctly superior efficacy or safety as compared to existing medical devices or therapies).

In FY 2014, five priority review products (all were new medical devices) were approved. The PMDA says 100% of these products being reviewed within 10 months, even though the aim for 2014 was 60%. Indeed, 60% of products were reviewed within 8.8 months. (As mentioned above, the stated aim is to have 80% of these products reviewed within 10 months by FY 2018.)

The number of approvals in this category was 5, which was close to the annual average, although FY 2013 had seen a bumper 14.

When it comes to review times for standard review of new products, 60% of products were reviewed within 5.6 months, and 98.4% of products were reviewed within 14 months – well above the target of 80% in 14 months by FY2018.

The total number of products going through the standard review process in both FY 2013 and 2014.was 62 – higher than average due to the particularly high number of MRI-compatible pacemakers and ICDs going through the system.

Device Review Targets In Japan

	Aim for FY 2014	Actual for FY 2014	Aim for FY2018	Total no of approved applications
Improved medical devices with clinical data	52% within 10 months	60% within 9.9 months	60% within 10 months	35
Improved medical devices without clinical data	52% within six months	60% within six months	60% within six months	213
Generic medical devices	52% within four months	60% within 3.9 months	60% within four months	920

(This article also appears in Scrip Regulatory Affairs. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)