In the wake of Shinya Yamanaka’s Nobel Prize for the discovery and utilization of iPS and with the intent of maintaining Japan’s position as the world leader in the development of regenerative medicine, MHLW and PMDA have issued policy guidance laying out a unique and accelerated regulatory pathway for regenerative therapies.
Leveraging the scientific and medical expertise of the IDA team, IDA can assist clients in designing development programs for regenerative medicines and gaining PMDA endorsement of pathways to approval for these therapies as shown below.
Benefits of new expedited approval system for Regenerative Medicines
- Significant reduction in development costs prior to initial marketing authorization
- Reduction in required documentation for initial NDA application
- Initial NDA review period shortened by over 50% (reduced to 6 months)