Overview
In Japan, the Orphan Drug Designation (ODD) system is a pivotal regulatory framework designed to encourage the development of medical devices targeting rare diseases. This initiative aims to address unmet medical needs by providing various incentives to manufacturers, ensuring that patients with rare conditions have access to essential medical technologies.
Introduction
Japan’s Orphan Drug Designation (ODD) system plays a crucial role in fostering the development of medical technologies aimed at treating rare diseases. By offering various incentives to manufacturers, this regulatory framework encourages innovation and ensures that patients with rare conditions gain access to essential treatments. As Japan continues to refine its ODD system, the focus remains on addressing unmet medical needs, streamlining regulatory processes, and accelerating the availability of life-saving medical technologies.
Criteria for Orphan Medical Device Designation
To qualify for orphan designation in Japan, a medical device must meet the following criteria:
- Prevalence: The device should be intended for use in fewer than 50,000 patients within Japan. This threshold underscores the commitment to supporting innovations for conditions that, due to their rarity, might not be commercially viable without regulatory incentives.
- Medical Need: The device must address a serious disease, including those that are difficult to treat. It should either offer a treatment where none exists or provide significant advantages in efficacy or safety over existing options.
- Development Feasibility: There should be a clear scientific rationale for the device’s use in the targeted condition, accompanied by a well-structured development plan. This ensures that the proposed solution is both innovative and practically achievable.
Incentives for Developers
Once a medical device receives orphan designation, developers can access several benefits designed to mitigate development challenges:
- Financial Grants: The National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN) offers subsidies to offset research and development expenses. These grants can cover up to half of the direct costs associated with bringing the device to market.
- Preferential Tax Treatment: Developers may be eligible for tax credits amounting to 12% of the R&D expenses incurred during the NIBIOHN subsidy period, excluding the subsidized amount. This financial relief aims to reduce the economic burden on innovators.
- Priority Review: Orphan-designated devices are fast-tracked through the regulatory review process, ensuring that they reach the market more swiftly to benefit patients in need.
- Extended Re-examination Period: Post-approval, these devices enjoy an extended re-examination (market exclusivity) period of up to seven years, during which similar products cannot enter the market. This exclusivity encourages investment by providing a competitive edge.
Application Process
The journey to obtaining orphan designation involves several key steps:
- Consultation Request: Developers submit a consultation application to the Evaluation and Licensing Division of the Pharmaceutical and Food Safety Bureau within the Ministry of Health, Labour and Welfare (MHLW). This initiates a dialogue to discuss the potential designation.
- Consultation Meeting: A formal meeting is held to evaluate the device’s eligibility, focusing on patient population size, medical necessity, and development feasibility. This collaborative discussion ensures that all criteria are thoroughly assessed.
- Submission of Application: Following a positive consultation, a detailed application is submitted, including data on patient numbers, medical need, scientific rationale, and a comprehensive development plan. This documentation provides the basis for the designation decision.
- Review and Designation: The application undergoes scrutiny by the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Upon approval, the device is officially designated as an orphan medical device, unlocking the associated incentives.
Conclusion
Japan’s ODD system plays a crucial role in fostering the development of medical devices for rare diseases. By offering financial support, tax incentives, expedited reviews, and market exclusivity, the framework not only motivates manufacturers to innovate but also ensures that patients with rare conditions have timely access to life-changing medical technologies.
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References
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.