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Supporting international business matching, LSMIP propritizes "Speed" and "Accuracy" in out service.
Please be noted that contents are in English/Japanese, translated on a request basis from authors/members.
国際間のビジネス・マッチングを促進するため、LSMIPでは情報発信の迅速性・正確性を重視しております。
コンテンツは各言語(英語、日本語)でお読みいただけますが、必要に応じて翻訳する場合があります。

Overview

1

Priority Review System for Drugs and Medical Devices in Japan

There are various priority review systems to provide the necessary useful new drugs and medical devices to the market as quickly as possible. Following the US FDA's first track system, Japan’s first general priority review system was established in the 1990s. Since then, various new priority review systems, summarized below, have been established and applied.                                                        
  • Target market
    Japan
  • Business category
    Pharmaceutical, Biopharmaceutical, Regerative medicine
  • Business function
    Regulatory >
  • Keyword
  • Author
    "Representative author" of "CM Plus Corporation"
  • Availability
    Membership

Detail

* This article has Japanese translation, following to the original text in English.

  There are various priority review systems to provide the necessary useful new drugs and medical devices to the market as quickly as possible. Following the US FDA's first track system, Japan’s first general priority review system was established in the 1990s. Since then, various new priority review systems, summarized below, have been established and applied.

Index
1. Orphan drug priority review system
2. SAKIGAKE (Pioneer) Review Designation System
3. Conditional Early Approval System
4. Conditional and Time-limited Approval System for regenerative medicines
5. The general priority review system

 
(Continued)

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