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Country
Industry
Pharmaceuticals, Japan
Pharmaceutical Registration in Japan - April 2010
Market Research Report

Code: 69881004
Price: $110.00

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FREE! Table of Contents in PDF format with Page Numbers
Table of Contents

Executive Summary
Pharmaceutical Registration Timeline
Regulatory Agencies
Ministry of Health Labour and Welfare
Pharmaceutical and Medical Devices Agency
The Pharmaceutical Affairs and Food Sanitation Council
National Institute of Health Sciences
Table 1: Websites for Japanese Health Regulatory Agencies
Laws and Regulations
Definition of Pharmaceuticals
Registration Procedures
What Pharmaceuticals Need to be Registered
What Information is Required During the Registration Process?
PMDA Consultations
PMDA Review Process
Standards
Market Authorization Holder
What Forms are used to apply for New Drug Registration?
How Much Does Registration Cost?
How Long Does the New Drug Review Period Take?
Packaging/Labeling Requirements

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