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Symposium Report Co-Authored by EPS Representative Director Noriyuki Takai Published in Clinical Pharmacology & Therapeutics

EPS is pleased to announce that a symposium report co-authored by EPS Representative Director Noriyuki Takai has been published in Clinical Pharmacology & Therapeutics, a leading international journal in the field of clinical pharmacology. The report is based on discussions from a joint symposium organized by the Pharmaceuticals and Medical Devices Agency (PMDA), the Japan Pharmaceutical Manufacturers Association (JPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).
The publication examines stakeholder perspectives on the role of Phase 1 clinical trials in Japanese participants prior to the initiation of multi-regional clinical trials (MRCTs). It highlights future approaches to enhancing global drug development, reducing barriers to patient access, and supporting more efficient and internationally harmonized clinical development pathways.
As Japan continues to strengthen its role in global clinical development, the report provides valuable insights into how regulatory authorities, industry associations, and development partners can work together to address challenges related to drug lag and accelerate the delivery of innovative therapies to patients.


Publisher: American Society for Clinical Pharmacology and Therapeutics
Journal: Clinical Pharmacology & Therapeutics
Article Title: Symposium Report: Stakeholders' Perspectives on Phase 1 Trials in Japanese Prior to Multi-Regional Clinical Trials and Future Pathways