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November 12, 2024

Regulatory Update in Japan: New Regulation Allows NDA Filing Without Japanese Data

A new administrative notice entitled ‘Basic Principles Regarding Japanese Data in Cases Where Confirmatory Clinical Trials for Drug Used in Rare...

January 29, 2024

New Regulations Expected to Accelerate Drug Development in Japan

Changes in Japan's Regulatory Approach Facilitate Entry for Overseas Emerging Biopharma Companies Authors:Takuya Higuchi and Hayato SawadaInnovative...

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Regulatory Update in Japan: New Regulation Allows NDA Filing Without Japanese Data

New Regulations Expected to Accelerate Drug Development in Japan

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Regulatory Update in Japan: New Regulation Allows NDA Filing Without Japanese Data

New Regulations Expected to Accelerate Drug Development in Japan

Coming to America - Successfully Tackling the FDA Landscape

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By Phase

LINICAL

White Papers

Regulatory Update in Japan: New Regulation Allows NDA Filing Without Japanese Data

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New Regulations Expected to Accelerate Drug Development in Japan

Posts about Regulatory

Regulatory Update in Japan: New Regulation Allows NDA Filing Without Japanese Data

New Regulations Expected to Accelerate Drug Development in Japan

Coming to America - Successfully Tackling the FDA Landscape

SIGN UP FOR OUR NEWSLETTER