BPB Reports

Paper Details

BPB Reports
Vol. 8 No. 2 p.50-63 2025
Meeting Report
Enhancing Value of Global Pharmacopoeia Standards: Summary of Joint USP-MHLW/PMDA Workshop
  • Hikoichiro Maegawa (Division of Pharmacopoeia and Standards for Drugs, Office of Review Management, Pharmaceuticals and Medical Devices Agency / maegawa-hikoichiro@pmda.go.jp)
Hikoichiro Maegawa 1) , Kevin Moore 2)
1) Division of Pharmacopoeia and Standards for Drugs, Office of Review Management, Pharmaceuticals and Medical Devices Agency , 2) Pharmacopeial Collaboration, United States Pharmacopeia, MD, USA
Received: March 21, 2025;   Accepted: March 26, 2025;   Released: April 23, 2025
Keywords: pharmacopoeia, standards, harmonization, USP, PMDA
Abstracts

USP and MHLW-PMDA held a joint workshop on September 10-11, 2024 in Tokyo, Japan1). This workshop was organized by the United States Pharmacopeia (USP) in collaboration with Japan’s Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). This workshop aimed to address critical issues in pharmaceutical quality and foster international collaboration between our two organizations and critical stakeholders. The workshop covered a range of topics, including the harmonization of standards with a specific focus on the inaugural pilot between USP and JP on the harmonization of a drug substance monograph and a drug product monograph, as well as on ICH Q2(R2)/Q14. Participants discussed advancements in quality testing, particularly for high-risk excipients like ethylene glycol and diethylene glycol, and shared insights on managing contamination issues. The event also explored the integration of emerging technologies such as quantitative nuclear magnetic resonance (qNMR) and the challenges associated with complex generics. Overall, the USP-MHLW/PMDA joint workshop underscored the commitment of both organizations to advancing public health through the development and harmonization of high-quality standards. By fostering collaboration and innovation, the workshop aimed to enhance the safety, efficacy, and accessibility of medicines globally.