Reviews

Links to major regulatory information of Reviews.

Regulations and Notifications

Application for Approval

• Basic Principles on Japanese Clinical Trial Data for Drugs for Rare Diseases, etc., for Which Confirmatory Clinical Trials Have Been Conducted Only Overseas[88.48KB]

October 23, 2024 PMSB/ELD Notification No. 1023-3

Submission/Application

• Submitting documents to be attached in the application for approval of new ethical drugs[143KB]

September 6, 2024 Administrative Notice

Review Timeline

• On the Standard Review Timeline for New Drug Applications[111.86KB]

March 30, 2012 PFSB/ELD Administrative Notice

• Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time[186.25KB]

January 17, 2011 PFSB/ELD Administrative Notice

• Points to Consider for Reducing Total Review Time for New Drug Applications[38.26KB]

June 9, 2010 PFSB/ELD-CND Administrative Notice

Early Approval System

• Partial Revision of “Handling of Conditional Approval of Drugs”[122KB]
  October 23, 2024 PMSB/ELD Notification No. 1023-2

• Implementation of a Conditional Early Approval System for Pharmaceutical Products[300.82KB]

October 20, 2017 PSEHB/PED Notification No. 1020-1

Review Process

• Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drug

April 17, 2008 Pharmaceuticals & Medical Devices Agency

Related Information

Promoting Medical Product development in Japan

• Why Japan for drug development Vol.2 (presentation for ENDPOINTS Events) [2.39MB]

May 2025

• Why Japan for drug development Vol.1 (presentation for ENDPOINTS Events) [2.60 MB]

November 2024

• PMDA’s Support to Venture Companies [2.21 MB]

August, 2024

Frequently Asked Questions (FAQ)

• Reviews