The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.
At the steering council meeting on 31 July 2020, the PMDA reported the results of their evaluation of operating performance from April 2019 to March 2020 (FY2019). The reports are posted on the PMDA website, which at the time of this blog post, are available only in Japanese
As for the total review periods from application to approval, timeline targets were achieved in every category of pharmaceutical products, medical devices, IVDs and regenerative medicine products. The definition of the reviewing applications and the data for medical device and IVD products are summarized below.
Reviewing Applications Definitions
New Medical Device
A device with clearly different principle, configuration, usage, intended use, or performance, as compared with existing devices.
Generic Medical Device
A device which is substantially equivalent to a predicate device
Improved Medical Device
A device that does not fall under “new medical device” or “generic medical device”
Types of Review
Designated orphan drugs medical devices are subject to priority review so that products may be supplied to clinical settings at the earliest possible opportunity.
The Sakigake Designation System exists to promote R&D in Japan, aiming at early practical application for innovative products. It applies to medical products for diseases that are in urgent need of innovative therapy. These products must satisfy the following two conditions: 1) the product is first developed and plans to apply for approval in Japan; and 2) the device shows prominent effectiveness in comparison to existing therapies.
Timeline Data for Approval of New Medical Devices
|Application Category||New Standard (Months)||New Priority (Months)||New Sakigake (Months)|
|80th Percentile Total Months to Approval (Target)||11.1
|Number of Approved Application||27||3||2|
*Only two products followed the New Sakigake review, and the total months of both products are 5.1 months.
Timeline Data for Approval of Improved/Generic Medical Device
|Application Category||Improved, with Clinical Data (Months)||Improved, without Clinical Data (Months)||Generic (Months)|
|60th Percentile Total Months to Approval (Target)||8.6
|Number of Approved Application||43||206||719|
Timeline Data for Approval of IVDs
|Category||Products requiring Meeting with External Experts (Months)||Standard (Months)|
|50th Percentile Total Months to Approval (Target)||11
|80th Percentile Total Months to Approval (Target)||No target/data||6.8
|Number of Approved Application||41||63|
While timeline review periods vary on many factors, including application materials and communications with reviewers, the above data should serve as a useful reference for global manufacturers to estimate time to regulatory approval in Japan.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with Japan’s PMDA and MHLW. Our internal teams of medical device development experts communicate with Japanese entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.
Learn more about NAMSA’s regulatory service offerings by visiting namsa.com/services/regulatory-and-quality-consulting/. We also invite you to get in touch by submitting a request at: namsa.com/locations-contact/.
Takashi Tanaka, PhD, RAC
Takashi Tanaka, PhD, RAC serves as Regulatory Consultant for NAMSA Japan. His past experience as Regulatory Manager at various global medical device companies includes registration for every class of medical device to ensure regulatory compliance. His work covers regulatory strategy assessment, preparation for regulatory documentation, and consultation support with regulatory bodies in Japan. Takashi has a PhD in Medical Sciences received from Kyoto University.