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History and overview
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for supervising Japan’s medical regulatory procedures, conducting reviews of pharmaceutical and medical device products, and providing recommendations to the Ministry of Health, Labor, and Welfare (MHLW). On April 1, 2004, the Pharmaceuticals and Medical Devices Agency (PMDA) was officially established and commenced its operations.
The primary objective of PMDA is to enhance public health in Japan through three main initiatives. First, it aims to offer prompt relief to individuals who have experienced health issues due to adverse drug reactions, which is known as “Relief Services for Adverse Health Effects.” Second, the PMDA offers consultation and conducts thorough evaluations of drugs and medical devices, assessing their quality, efficacy, and safety – this initiative is termed “Product Reviews.” Third, the PMDA plays a crucial role in gathering, analyzing, and disseminating post-market safety information to ensure ongoing safety measures, referred to as “Post-marketing Safety Measures.”
PMDA Medical Product Registration
In the process of developing a new medical product, a medical company must implement multiple tests and studies to validate the product’s quality, efficacy, and safety. These tests and studies are essential to gather evidence supporting the medical product’s attributes. Once the company (applicant) obtains results from these tests/studies, they submit an application seeking regulatory approval of the product to the PMDA and if approved, product is allowed to be used for commercial purposes.
A drug will be classified as a “new (prescription) drug” if it contains a new active ingredient, composition, dosage, administration, or indication different from previously approved drugs. The application includes data related to quality, non-clinical studies, and clinical trials. The PMDA assesses aspects like quality, clinical implications, toxicology, pharmacology, pharmacokinetics, biostatistics, and epidemiology. External experts are consulted during the review process (Expert Discussions) to tap into specialized disease expertise. Afterward, the PMDA creates review reports for the new drug application and submits them to the Minister of Health, Labor, and Welfare (MHLW). The final decision on product approval is made by the Minister after they seek additional guidance from the Pharmaceutical Affairs and Food Sanitation Council (PAFSC).
Upon its establishment, the PMDA had to address the issue of “drug lag” in Japan, which caused delays in accessing new drugs already approved overseas. To overcome this challenge, the PMDA focused on improving its consultation and review activities, leading to an improved approval process. Continuing its efforts, PMDA aims to maintain a consistent and predictable review process. The agency sets a target review time of 12 months for new drugs (with a reduced time of 9 months for priority review products) to ensure timely approval and access to new drugs.
PMDA medical device registration
PMDA medical device registration procedures depend on the risk classification of the device. The PMDA primarily focuses on regulating high-risk medical devices. Medical devices not subject to PMDA review require certification by third-party certification bodies before they can be marketed.
The review process for medical devices involves a diverse team within the PMDA. External experts are consulted during the review (Expert Discussions) to ensure specialized disease expertise.
Medical devices in Japan are categorized into 4 classes:
Class I medical devices are devices with very low risk and only require notification to the PMDA for regulatory purposes. Examples include small steel devices like scalpels and tweezers.
Class II medical devices are devices with relatively low risk and require to be certified by a registered certification body. Examples include MRI systems, electronic endoscopes, and dental alloys.
Most Class III medical devices involve devices with relatively high risk and requires a more stringent regulatory process, including review by the PMDA and approval by the MHLW. Examples include dialyzers, bone prostheses, and automated external defibrillators (AEDs).
Class IV comprises highly invasive devices that may pose serious life-threatening risks if they malfunction. These devices also need to be reviewed by the PMDA and then approved by the MHLW. Examples include pacemakers, artificial cardiac valves, and stent grafts.
The PMDA works continuously to ensure a more predictable review process, with the goal of completing the review for new medical devices in 14 months. In the case of priority review applications, the review time is reduced to 10 months.
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs.
Written by: Ames Gross – President and Founder
Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:https://www.pmda.go.jp/english/