USP in Japan 2024: Advancing global health through collaboration
In September 2024, the U.S. Pharmacopeia (USP) hosted a series of significant events in Japan, marking important strides in our mission to improve global health through public standards and related programs. These convenings brought together key stakeholders from across the Asia-Pacific (APAC) region, fostering dialogue, collaboration, and innovation in pharmaceutical quality and regulatory science.?
USP APAC Regional Chapter Meeting: A Milestone in Global Engagement?
The 4th USP Asia-Pacific Regional Chapter Meeting, convened in Tokyo on September 9th under John Lim's leadership, highlighted the forum’s evolution since its inception as a virtual gathering during the pandemic. The meeting underscored several critical points, including the significance of global collaboration in a time of de-globalization and geopolitical instability, the need for innovative approaches to address opportunities and challenges posed by new therapeutics and system gaps, the ongoing necessity to tackle fundamental issues affecting product quality and supply chain integrity in developing settings, the evolving nature of regulation with increasing convergence of health products and health services regulation, and the continued importance of capacity building and regulatory systems strengthening across all stakeholders. Three critical focal points emerged for future action: integrating quality standards into digital formats, tackling widespread challenges such as impurities, and improving access to biologics and biosimilars.??
This convening also provided a platform to discuss USP's transition into its new five-year cycle (2025-2030), focusing on impactful resolutions and priority areas. Nearly 40 stakeholders from nine nations- Australia, China, Indonesia, Japan, Korea, Malaysia, Pakistan, the Philippines, and the United States – including executive directors and senior officials from their respective National Regulatory Authorities, contributed to shaping the future of global pharmaceutical quality.??
Bilateral Meetings: Strengthening International Collaborations?
In addition to the chapter meeting, we held several high-level bilateral discussions that promise to strengthen our international partnerships.?
USP-Indonesia Food and Drug Authority (FDA) Bilateral Meeting?
USP CEO Dr. Ronald T. Piervincenzi, as well as Tony Lakavage, SVP of Global External Affairs, Anthony Tann, Senior Director, General Manager, and representatives of the APAC USP team, convened a strategic summit on September 9th with the new Head of Indonesia FDA, Professor Dr. Taruna Ikrar, and his delegation. This meeting served multiple purposes: introducing US Pharmacopeia to Professor Dr. Ikrar, discussing ongoing collaborations, and exploring future opportunities in pharmacopeial harmonization, scientific exchanges, and regulatory strengthening initiatives. The dialogue extended into the APAC Convention Chapter Meeting, where Professor Dr. Ikrar's team shared valuable insights on Indonesia's response to the global Ethylene Glycol (EG) and Diethylene Glycol (DEG) crisis, catalyzing a broader discussion on regulating excipient quality to ensure medicine safety. This summit culminated in a commitment to strengthen the enduring USP-Indonesia FDA partnership through enhanced scientific exchanges, expanded training programs for regulators and industry utilization of USP standards, and collaborative efforts to advance trade and the supply of quality medicines to improve access to quality medicines for people in Indonesia and across the Asia-Pacific region.??
USP-Pharmaceuticals and Medical Devices Agency?(PMDA) Bilateral Meeting?
Members of USP’s Executive Team, including Dr. Ronald T. Piervincenzi, CEO; Amanda Cowley, SVP of Legal, Strategy & People; Tony Lakavage, SVP of Global External Affairs; together with Anthony Tann, Senior Director, USP APAC; Dr. Kevin Moore, Senior Pharmacopeial Collaboration Manager, Documentary Standards and Compendia Policy; Ms. Ruth Lee, Associate Director, International Government and Regulatory Affairs; and Masahide Tamura, Strategic Customer Development Manager, Japan;?had the honor of meeting Dr. Yasuhiro Fujiwara, CEO of PMDA. The meeting, held the morning of September 10th and ahead of the bi-annual joint USP-PMDA workshop, provided a platform to further deepen a partnership of more than 30 years between USP and the PMDA.??
The USP delegation held a lengthier discussion with key partners in Japan from PMDA, the Japanese Ministry of Health, Labour, and Welfare (MHLW), and the National Institute of Health Sciences (NIHS).??
This exchange was an opportunity to positively reflect on the continuing and growing partnership and active collaboration between USP and Japan on improving standards for access to quality medicines. The meeting covered a comprehensive agenda, beginning with an overview of USP's new 5-year strategic cycle (2025-2030) and an exploration of PMDA's international expansion efforts in Bangkok and Washington, D.C. Discussions then focused on strategies to advance USP and Japan's joint leadership within the Pharmacopeia Discussion Group (PDG), as well as avenues to support MHLW's objectives for quality medicine access and standards utilization. The participants also worked on developing a long-term roadmap for joint initiatives, including plans for future USP-PMDA workshops. Importantly, the meeting yielded concrete results, with the identification of immediate collaboration opportunities, particularly the development of two pilot monographs.??
This meeting reaffirmed the shared commitment of USP and Japanese regulatory bodies to deepen their collaboration, with a focus on harmonizing and expanding the use of quality standards for medicines. All parties expressed enthusiasm for advancing this collaboration, recognizing its potential to significantly shape global pharmaceutical standards and practices.??
USP-MHLW/PMDA Joint Workshop?
领英推荐
Following these bilateral meetings, we held a hybrid Joint MHLW/PMDA-USP Workshop “Role of Quality in Pharmaceuticals” on September 10th and 11th with close to 360 industry and regulatory stakeholders to discuss developing new standards, harmonizing standards to facilitate regulatory review of new drug products, enhancing trade between the US, Japan, and Southeast Asian countries, and strengthening the supply chain for biologics and other critical medicines. The workshop began with opening remarks from Dr. Piervincenzi and Dr. Suzuki, closed with remarks from Dr. Jaap Venema and Dr. Saito, and focused on four tracks, (a) advancing harmonization of standards, (b) excipient quality, specifically around DEG/EG contamination, (c) future prospects for collaboration in areas such as complex generics and qNMR, and (d) a session dedicated to nitrosamine impurities. This workshop exemplified the collaborative spirit that is essential for addressing the complex challenges facing our industry today.?
Memorandum of Understanding with Chung-Ang University (CAU) in Seoul, Korea??
USP is pleased to announce a memorandum of understanding with CAU signed on September 11th.? The collaboration between USP and CAU will focus on strengthening cooperation in researching and developing new dietary ingredients and food products. Key objectives of this collaboration include increasing awareness about the importance of quality and safety in new food ingredients, promoting closer collaboration between CAU and USP, establishing a robust foundation and mechanisms for ongoing joint efforts, and identifying areas of mutual interest for potential future projects. Both USP and CAU are excited about the impact of this collaboration and look forward to sharing progress and innovations in the coming months.?
USP Endotoxin Workshop?
The week concluded with over 30 attendees for a specialized Endotoxin Workshop on September 12th that brought together industry leaders to explore the latest advancements in endotoxin testing and its crucial role in ensuring the safety and quality of biologics. Huiping Tu and Minkyung Kim led discussions on two key topics: USP's Global Biologics strategies and advancements in endotoxin testing methods. In the biologic's strategy session, USP’s offerings and initiatives to support biologics development worldwide were outlined. Separately, a major point of discussion focused on moving towards alternative methods for bacterial endotoxin and rabbit pyrogen testing, currently governed by USP Chapters <85> and <151>. The approval of New Chapter <86>, which promotes recombinant reagents for endotoxin testing, marks a significant step toward more ethical and sustainable practices. The release of a new endotoxin reference standard lot was also highlighted, along with discussions on the Monocyte Activation Test (MAT), a human-cell-based alternative to traditional pyrogen testing methods. The strong interest from external stakeholders in further collaborations, particularly in the biologics field, was extremely encouraging. Moreover, several participants expressed interest in applying for USP expert committees, a positive step towards strengthening global collaboration and knowledge sharing.?
Looking Ahead?
As we reflect on this eventful week in Japan, we are filled with optimism about the future. These convenings represent a significant milestone in USP's ongoing efforts to foster international collaboration and advance global health. Moving forward, we are excited to build on this momentum, forging new collaborations and initiatives that will contribute to ensuring the quality, safety, and efficacy of medicines worldwide.??
We extend our sincere gratitude to all participants, collaborators, and stakeholders who made these events a success. Your engagement and commitment are invaluable as we work together to improve global health through public standards and related programs. The conversations started in Tokyo will undoubtedly continue to shape our collective efforts in the months and years to come, driving us towards a healthier, more connected world.?
Contact Ruth Lee at [email protected] for more information about USP Asia-Pacific events.?