What's New (Reviews)

October 7, 2025

Review

New

English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
October 6, 2025

Review

New

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
October 2, 2025

Review

New

Concept of New Approach Methodologies (NAMs) use in quasi-drug applications (Early Consideration) and Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker (Early consideration) posted
September 30, 2025

Review

List of Approved CDx（Companion Diagnostics）: Updated Sep 19, 2025
September 5, 2025

Review

GMP / GCTP Annual Report FY 2024 posted
September 2, 2025

Review

English translation of review report: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
August 7, 2025

Review

List of Approved Medical Devices: April 2004 to December 2024
July 30, 2025

Review

New radiopharmaceuticals page created
July 11, 2025

Review

Information on biosimilars is updated
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 14, 2025

Review

The information of New Drug Review with Electronic Data updated
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)
August 23, 2024

Review

PMDA’s Support to Venture Companies posted
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)