Expanding to Asia can be a logical next step for pharma companies looking to grow beyond the mature markets of North America and Europe. Recent developments in market access and regulatory rules in Japan and South Korea have paved the way for such expansion, by introducing a newly consultative approach to clinical trials, lowering some of the barriers, shaving time off review processes, and otherwise making an entrée into the Asia markets a newly viable reality for pharma organizations.
In this whitepaper, explore:
- Japan's PMDA services
- Expedited review and conditional approval advancements
- New Cost Effectiveness Assessment (CEA) criteria
- South Korea's reduced drug review period
- And more