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Related Experiment Video

Updated: Jun 4, 2025

Dynamic Digital Biomarkers of Motor and Cognitive Function in Parkinson's Disease

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PMDA Perspective on Use of Real-World Data and Real-World Evidence as an External Control: Recent Examples and

Junichi Asano¹, Hiromi Sugano¹, Hiroyuki Murakami²

¹Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

Clinical Pharmacology and Therapeutics

|January 3, 2025

Summary

Real-world data (RWD) and real-world evidence (RWE) are increasingly used for drug approval in Japan, especially for rare diseases. Careful consideration of RWD/RWE across all study stages is crucial for regulatory review and decision-making.

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Area of Science:

Pharmacovigilance and Drug Development
Regulatory Science
Health Informatics

Background:

Discussions on real-world data (RWD) and real-world evidence (RWE) often prioritize drug development over post-marketing surveillance.
In Japan, RWD/RWE has been practically applied as an external control for drug approval, particularly for orphan diseases with low feasibility for randomized controlled trials.

Purpose of the Study:

To present Japan's regulatory review experience with RWD/RWE for efficacy evaluations using external controls in new drug applications.
To describe regulatory considerations for RWD/RWE utilization in drug evaluation and approval.
To facilitate appropriate drug development and discussions regarding RWD/RWE with regulatory agencies like PMDA.

Main Methods:

Review of regulatory submissions for new drug applications in Japan that utilized RWD/RWE as an external control for efficacy evaluation.
Analysis of regulatory considerations and decision-making processes related to RWD/RWE in drug approval.

Main Results:

RWD/RWE has been utilized as an external control for drug approval in Japan, especially for orphan diseases.
The use of RWD/RWE provides supplementary information supporting regulatory review.
Consideration of RWD/RWE across all study phases (planning, analysis, interpretation) is essential.

Conclusions:

Accumulating regulatory experience with RWD/RWE in Japan will enhance understanding and improve regulatory decision-making for drug approvals.
Appropriate drug development using RWD/RWE and open discussion with regulatory bodies are encouraged.
Further refinement of RWD/RWE utilization will support robust drug evaluation and approval processes.