PMDA List of articles

ELIQUENT 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 […]

2026.08.12

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Early Consideration for the Revision of Japan’s Regulatory Guidelines on Prototype Vaccines for Pandemic Influenza Preparedness

Introduction to the Early Consideration On July 31, 2026, Japan’s Pharmaceuticals and Medical Devices Agency ( […]

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 […]

2026.02.26

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Japan Enhances Global Clinical Trial Access Through One-Stop Window and PMDA Collaboration

Introduction to the New Clinical Trial Initiative According to the official notification issued by Japan’s Min […]

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