Whitepaper
Vol.1 Pharmaceutical Regulations in Japan
We introduce pharmaceutical regulations in Japan and the differences between Japan and US
Overview
- Standard Process in Drug Development in Japan
- Clinical Data Package/Recent Regulation Changes
- Total Review Period for New Drugs
- Japan’s Development Support Criteria
- Regulatory Programs between Japan and US
- PMDA overseas office (scheduled to open)
- Overview Japan’s Drug Pricing System
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