2019 - Japan: Regulatory Compliance Requirements for Life Science Products

Part I: Japan Regulatory Compliance
Japan’s Regulatory Structure for the Life Science Product Industries
Country Healthcare System
Regulatory Framework: Key Agencies Involved / Reporting Structure
MHLW (Ministry of Health, Labour and Welfare)
PMDA (Pharmaceutical and Medical Device Agency)
MoH Consulting Committees
Consensus Decision-Making: Strengths, Timeline Impacts
Patent System
Pharmaceutical Affairs Law (PAL)
Beginning Your Company Involvement in Japan
Local Office and Personnel Requirements
Language Requirements
License Types
Options for Importers / Overseas Manufacturers
Objectives of the Rules Governing Medicinal Procedures
Life Science Regulations and the Regulatory Processes in Japa
Conducting Clinical Trials
New Product Registrations
Handling of Risk Management
Variations to Licenses
Post-Marketing Requirements
License Renewals
Japan’s Use of ICH Standards / Principles
GCP
GMP
Quality Documents and Standards
CTD / e-CTD Submissions
Starting-Up and Conducting Clinical Trials
Who can conduct Clinical Trials?
When are they needed?
Start-up Process & Timelines
Part II: Marketing Authorization Processes – Product Registrations / Licensing
Drugs
Medical Devices
Biologics
Combination Product
Drug Master File (DMF) Use in Japan
Labeling Requirements
Packaging Information Leaflets
Variations: Changes to Marketed Products
Types of Variations
Dossier Maintenance Expectations
License Renewals
Process and timing for Renewing Licenses
Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
Comparison of Processes
Expected Timelines
Accepted Practices
How and When to Influence the Regulatory Process
Japanese Way of Thinking / Cultural Issue
Effective Approaches to Meet Regulators
The Do’s and Don’ts of Regulatory Involvement in Japan
Utilizing Local Regulatory Resources