Introduction to Japanese Institutions and Regulatory Authorities
The course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the structure and organization of Japan’s government institutions and its lawmaking process. It explores the functions, structure, and responsibilities of the Ministry of Health, Labor and Welfare (MHLW) and of the Pharmaceutical and Medical Devices Agency (PMDA). The course reviews key Japanese pharmaceutical legislation and provides an overview of the new drug application (NDA) review process. The course concludes with a review of cultural considerations that will help learners better understand Japan’s business code and practices.
- Japanese pharmaceutical legislation
- Japan’s MHLW
- Japan’s PMDA
- Japan’s business code and practices
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Describe the structure and organization of the Japanese government
- Outline the lawmaking process
- Identify the functions and organization of the Ministry of Health, Labor and Welfare
- Examine the role of the Pharmaceutical and Medical Devices Agency
- Review the history of pharmaceutical legislation
- Analyze the New Drug Approval Process
- Understand the code of business conduct in Japan
The course takes an average of two hours to complete.