What's New (Reviews)

February 12, 2026

Review

New

One-Stop Service Platform by ENSEMBLExJ page created

February 5, 2026

Review

Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation (Early Consideration), Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals (Early Consideration),Consideration in the development of drugs for hypertrophic cardiomyopathy (Early Consideration) posted

February 4, 2026

Review

List of Approved Medical Devices: April 2004 to June 2025

January 29, 2026

Review

Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted

January 26, 2026

Review

Software as a Medical Device (SaMD) page updated

January 22, 2026

Review

English Translation of Review Report: Lialda (Partial Change Approval) and Zepbound

January 19, 2026

Review

Information on biosimilars is updated

January 9, 2026

Review

English translation of review report: ENDEAVORRIDE

December 23, 2025

Review

List of Approved Products: April 2015 to November 2025

December 17, 2025

Review

List of Approved Drugs: April 2004 to June 2025

December 12, 2025

Review

English Translation of Review Report: JACC (Partial Change Approval)

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 14, 2025

Review

Information on new modalities is now available

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

April 18, 2025

Review

“Initiatives to Promote Pediatric Drug Development” posted

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)