Japan’s commitment to promoting the development of and facilitating patient access to new therapies for rare diseases is one of the strongest in the world.
IDA has extensive experience in assisting clients in gaining Orphan Drug Designation (ODD) from MHLW as well as in obtaining development subsidies from the National Institute for Biomedical Innovation (NIBIO). IDA’s team of experts can guide clients through the complex process of working with MHLW, PMDA and NIBIO in order to obtain the benefits of ODD described below.
Benefits of ODD
- Priority consideration for face-to-face PMDA consultations and lower consultation fees
- Priority J-NDA review (review period shortened by 25%) and lower review fees
- Additional R&D guidance from MHLW, PMDA and NIBIO
- NIBIO subsidies for up to 50% of Japan development costs
- Tax credit for 12% of study expenses (not including grant subsidies)
- Premium pricing of 10-20% for addressing a small market (in addition to any premium pricing received due to innovative characteristics)
- 25% extension of clinical data exclusivity period (lengthened to 10 years)
Conditions for ODD
- Potential target patient population of approx. <50,000 or <180,000 for designated "Nanbyou" (Japan Intractable Diseases)
- Product addresses a serious unmet medical need
- No alternative drugs or treatments are available or the product is a significant improvement in efficacy or safety compared with current therapies
- A high probability of development success