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Japan s Pharma and Medical Devices Amendment Demands Compliance
Pharmaceutical and biotech companies face new structural challenges and considerations for entry into the Japanese market. These challenges could result in a lack of bandwidth that hampers corporate growth in Japan.
United states
Godo kaisha
Ministry of health
Safety of products including pharmaceuticals
Products including pharmaceuticals
Medical devices
Fundamental statute governing pharmaceutical
Medical device industry sees largest reform
Revised act
Sakigake review system
Conditional early approval system
Emerging need
Robust compliance
Good quality practice
Representative directors
Responsible officers
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