Japan’s Ministry of Health, Labor and Welfare (MHLW) is the regulatory body that oversees food and drugs in Japan, which includes creating and implementing safety standards for medical devices and drugs. In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA) is an independent agency that is responsible for reviewing drug and medical device applications. The PMDA works with the MHLW to assess new product safety, develop comprehensive regulations, and monitor post-market safety.
The Pharmaceuticals and Medical Devices Act (PMD Act)
Current Japan regulations are laid out in the Pharmaceuticals and Medical Devices Act (PMD Act), also known as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics. The PMD Act affects all aspects of Japanese medical product registration, including in-country representation, certification processes, licensing, and quality assurance systems. The PMD Act came into force on November 25, 2014 and replaced the Pharmaceutical Affairs Law (PAL). Key features of the regulations include:
- Some Class III medical devices are able to undergo third party certification.
- Medical software programs are independently regulated.
- Manufacturers are required to be registered rather than be licensed.
- Quality management systems (QMS) are streamlined. QMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual products.
Regulatory Approval for Medical Devices in Japan
In Japan, a medical device can be classified as a General Medical Device (Class I), Controlled Medical Device (Class II), or a Specially Controlled Device (Class III and Class IV), depending on the risk level. For General Medical Devices, only a notification/self-declaration is required, and the product does not need to undergo the approval process by the MHLW and PMDA. Controlled Medical Devices can be designated to be certified by an authorized third-party certification party or reviewed by the PMDA. Specially Controlled Medical Devices must be reviewed and approved by the PMDA and MHLW.
Regulatory Approval for Drugs in Japan
The PMDA reviews new drugs, generic drugs, OTC drugs/”behind-the-counter” (BTC) drugs, and quasi-drugs, and conducts re-evaluations of previously approved drugs. Orphan drugs and other priority drugs are given priority reviews in accordance with their clinical significance.
PMDA reviewers consider the following five main points when evaluating a new drug to determine the approval status:
- Has the reliability of the conducted studies and submitted documents been ensured?
- Is the efficacy in the study population considered to be more effective than placebo according to the results of properly designed clinical studies?
- Do the obtained results have clinical significance?
- Are there any unacceptable risks as compared to the benefits?
- Can the drug be supplied continuously with stable efficacy and safety from a quality assurance standpoint?
Regulatory Approval for Regenerative Medical Products
The PMDA defines cellular and tissue-based (regenerative medicine) products as processed human/animal cells or tissues that are intended to be used for:
- The reconstruction, repair, or formation of structures or functions of the human body
- The treatment or prevention of diseases
- Gene therapy
The PMD Act significantly shortens the phased clinical trial period for regenerative medical products so that they can be used on a conditional authorization basis in a much timelier manner.
For more detailed information about product registration and regulatory requirements for medical devices and pharmaceuticals in Japan, please see Medical Device Registration in Japan and Pharmaceutical and API Registration in Japan.
Japan Medical Device and Pharmaceutical Regulatory Resources
Japan Medical Device Regulatory Webcast
For the most comprehensive and detailed overview of the Japanese medical device regulations, view the Japan Medical Device Regulations Webcast. Key topics include PMDA consultations, device classification, Foreign Manufacturer Registration, Japanese GCP, product reimbursement, how to expedite product registration and maximize the use of foreign clinical data, and more.
Japan Drug Regulatory Overview Report
The Japan Drug Regulatory Overview Report provides an in-depth coverage of ethical, orphan, biological, and generic drugs in Japan, including details about drug classification, clinical trials, reimbursement, and pricing. Read the report to learn about the common issues regarding entry into Japan’s pharmaceutical market and tips for a successful registration and approval process.
Medical Device and Pharmaceutical Regulatory News from Japan
Pacific Bridge Medical releases timely news briefs on medical device and pharmaceutical regulatory affairs in Asia every month. Click here to view the latest updates on Japan’s regulations, including:
- Japan’s Push to Generics Means Added Challenges for Many Pharmaceutical Companies
- Japan Increases Medical Device Registration Fees
- Japan Expands Share of Generic Drugs
- Japan Pharmaceutical Market Set for Growth
- Japan Takes Leading Role in Regenerative Medicine
- Japan Announces April Price Changes for Devices and Drugs
- Japan Promotes Telemedicine by Removing Regulatory Hurdles
Recent Japan Medical Device and Pharmaceutical Publications
- Foreign Manufacturer Registration in Japan
- Strategies for Success in Japan’s Medical Device Market
- Japan Orphan Drug Update 2017
- Asia Aging Quickly, Many Medtech Opportunities
- 2016 Japan In Vitro Diagnostics Registration Update
- Japan Expands Proactive Measures to Fight Cancer Market
- How to Succeed in Japan’s Medical Device Market
- Do Your Homework Before Entering the Japanese Device Market!
- Medical Device Executives: Don’t Forget Japan
- New Japan Medical Device Regulations Went Into Effect Late Last Year