Orphan Drugs in the USA, European Union, and Japan

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, examines the orphan drug development programs established in the United States, EU, and Japan to encourage the research and development of orphan products. For the three regions, the course outlines the legislative and regulatory basis of the orphan pharmaceutical development programs; describes administrative, scientific, and financial incentives available to orphan drug sponsors; and explores the supervisory bodies and authorities involved in the pharmaceutical designation processes.

• Legislative and regulatory basis of the orphan pharmaceutical development programs
• Administrative, scientific, and financial incentives available to orphan drug sponsors
• Supervisory bodies and authorities involved in the pharmaceutical designation processes

Participants who complete this course should be able to:

• Identify legislative and regulatory basis of the orphan drug development programmes in the United States, European Union, and Japan
• Discuss the role of the supervisory bodies and authorities involved
• Examine the incentives available to orphan drug sponsors
• Describe the different orphan drug designation processes
• Compare the orphan drug programmes in the three regions

The course takes an average of 1.5 hours to complete.