This Japan drug regulatory PowerPoint presentation covers many basic issues for international drug companies looking to gain more knowledge about the Japanese drug market. It includes information on registering ethical, biological, orphan, and generic drugs in Japan. The presentation also provides information on drug classification, reimbursement, and clinical trials.
To download this report, please click on Japan Drug Regulatory Overview Report 2014
Table of Contents:
- Background; Japanese Pharmaceutical Laws and Organizational Bodies
- Drug Classification
- Ethical Drugs: Approval Application and Required Documents
- Drug Approval Flow Chart and Timeline
- Orphan Drugs
- Priority Review
- Outline for Approval of Orphan Drug
- Biological Products
- Generic Drugs
- Clinical Trials
- NHI Pricing and Reimbursement
- Other Key Issues
- Overall Recommendations for Product Registration in Japan