What's New (Reviews)

December 3, 2025

Review

New

Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development Stage（Early Consideration）posted

November 28, 2025

Review

Regulatory Information updated

November 28, 2025

Review

Quasi-Drugs page created

November 28, 2025

Review

Review Reports : Quasi-Drugs page created

November 28, 2025

Review

Others updated

November 26, 2025

Review

List of Approved CDx（Companion Diagnostics）: Updated Nov 20, 2025

November 26, 2025

Review

English Translation of Review Report: Andembry and Nuvaxovid (Partial Change Approval)

November 20, 2025

Review

English translation of review report: CureApp AUD A Digital Therapeutic to Reduce Alcohol Consumption

November 14, 2025

Review

Information on new modalities is now available

October 30, 2025

Review

List of Approved Medical Devices: April 2004 to March 2025

October 24, 2025

Review

Information on biosimilars is updated

October 14, 2025

Review

The information of New Drug Review with Electronic Data updated

October 10, 2025

Review

New Modalities and NAMs page created

October 6, 2025

Review

Rationalization of descriptions in the specification column in approval application forms for prescription drugs, Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with Manufacturing Process Changes, Handling of Prescription Drugs Having Different Crystalline Forms, etc., Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs posted

September 5, 2025

Review

GMP / GCTP Annual Report FY 2024 posted

July 30, 2025

Review

New radiopharmaceuticals page created

July 1, 2025

Review

List of Approved Drugs: April 2004 to March 2025

April 28, 2025

Review

English Translation of Review Report: Akuugo

April 18, 2025

Review

“Initiatives to Promote Pediatric Drug Development” posted

March 3, 2025

Review

List of Approved Products: April 2015 to September 2024

February 28, 2025

Int

The new website “For Industry - for development in Japan “ launched.

February 17, 2025

Review

Consideration in the development of drugs for pulmonary arterial hypertension (Early Consideration) posted

December 17, 2024

Review

Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)

June 21, 2024

Review

GMP compliance inspection updated

May 30, 2024

Review

Pamphlet of Regulatory Science Consultations is posted

September 26, 2023

Review

GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers

May 9, 2023

Review

Regulations Regarding Living Modified Organisms (Genetically Modified Organisms) posted

May 9, 2023

Review

Regenerative Medical Products Information posted

January 25, 2023

Review

Ministerial Ordinance on Good Clinical Practice for Drugs updated

September 16, 2021

Review

Q&A on the Master File (MF) System, Part III posted

June 12, 2015

Review

The Pilot Project in The Last Half of FY2014 (Outline and results)