Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development On-Demand Learning

Keyword(s) drug development; pharmaceutical market; Japan; PMDA; RWE; regulatory

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This on-demand 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 also be reviewed.

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Tag(s) On Demand Training, Regulatory, Pharmaceutics, Public Policy / Law, Drug Development

Description

This on-demand short course reviews significant changes in Japanese pharmaceutical regulations and procedures which impacts the development of new drugs in Japan as well as global development programs. Regulatory framework and reform as well as drug development processes and pathways will be highlighted. The use of real-world evidence and data for regulatory decisions in Japan will also be covered.

FEATURED TOPICS:

Japanese Pharmaceutical Market
Pharmaceutical Regulatory Framework in Japan
The "Drug Lag:" A Driver of Regulatory Reform
The Drug Development, Consultation, and Approval Process
Special Programs and Accelerated Pathways
Use of Real-World Evidence (RWE) and Real-World Data (RWD) for Regulatory Decisions in Japan
Multicourse Data
Analysis Methodologies