PMDA List of articles

ELIQUENT Japan > PMDA

2026.09.15

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Japan Joins FDA’s Project Orbis to Accelerate Global Oncology Drug Approvals

Introduction to Project Orbis is an international regulatory collaboration program established by the FDA Onco […]

2026.09.08

Drug,prescription,for,treatment,medication.,pharmaceutical,medicament,,cure,in,container

Comparison of Biosimilar Development Guidelines: Japan, EU, and United States

Overview This document provides a comparative analysis of biosimilar regulatory guidelines across Japan (PMDA/ […]

2026.08.17

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Early Consideration on Safety Measures for Bioequivalence Studies in Healthy Volunteers in Generic Drug Development in Japan

Introduction to Safety Considerations for Bioequivalence Studies According to the notification issued by the P […]

2026.07.07

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What scientific rationale and supporting evidence are required to substantiate the classification of a genetic alteration as a driver mutation in the development of Anti-cancer Drugs ?

Introduction to PMDA’s Early Consideration on Driver Mutations According to the Early Consideration docu […]

2026.06.24

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Early Consideration on Clinical Evaluation of Factor VIII and Factor IX Products for Pediatric Congenital Hemophilia in Japan

Introduction to Pediatric Hemophilia Indication Development in Japan According to the communication issued by […]

2026.06.08

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Considerations for Determining the Need for Comparative Efficacy Studies in Biosimilar Development in Japan

Introduction to PMDA’s Early Consideration on Comparative Efficacy Studies for Biosimilars According to the Ea […]

2026.05.13

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Early Consideration on Clinical Development of In Vivo Diagnostic Drugs in Japan

Introduction to Early Consideration on In Vivo Diagnostic Drug DevelopmentAccording to the Early Consideration […]

2026.04.27

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Early Consideration on Food Effect Evaluation for Oral Drug Products in Japan

Introduction to Early Consideration on Food Effect Evaluation According to the notification issued by Pharmace […]

2026.04.13

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PMDA Early Consideration on Clinical Trials with a Limited Number of Subjects: Key Considerations for Drug Development in Japan

Introduction to Small Sample Clinical TrialsAccording to the notification issued by the Pharmaceuticals and Me […]

2026.03.31

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Points to Consider for Clinical Development of PSMA-PET Radiopharmaceuticals in Japan

Introduction to Regulatory Considerations According to the document issued by the Pharmaceuticals and Medical […]

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