Already a DIA Member? Sign in. Not a member? Join.

Iniciar sesión

¿Ha olvidado su ID de usuario? or ¿Ha olvidado su contraseña?

Not a Member?

Create Account and Join

San Diego Convention Center

23 jun 2019 1:30 p.m. - 23 jun 2019 5:00 p.m.

111 W Harbor Drive, , San Diego, CA 92101 , USA

#35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

Perspectiva general

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.


An additional registration fee is required for all preconference short courses.

Back to DIA 2019 Short Courses

¿Quiénes deben asistir?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Objetivos de aprendizaje

At the conclusion of this course, participants should be able to:

  • Explain the major elements of the Japanese regulatory system;
  • Describe the regulatory procedures during development, registration, and post-approval;
  • Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.

¿Tiene una cuenta?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.