“14th Asia Pharmaceutical Association Cooperation Conference (APAC)” Held Mission: To swiftly deliver innovative medicines to the people of Asia

The APAC (Asia Partnership Conference of Pharmaceutical Associations) has been held since 2012 and marked its 14th edition in 2025. Approximately 700 people from Japan and abroad attended this conference, held on April 22, 2025, with 60% of the attendees coming from overseas.The conference featured five sessions and two keynote speeches addressing drug discovery, regulations related to submissions and approvals throughout the pharmaceutical lifecycle, and solutions to challenges in improving access to medicines, all of which sparked very lively discussions.

All APAC Staff


Please view the presentation materials from the APAC Conference on the APAC website below.
APAC: https://apac-asia.com/achievements/14th_apac.html

Below, we will provide a report following the program for the day.

Summary of Opening Remarks

Furthermore, it was stated that the APAC’s scope of activities will expand to address changes in the pharmaceutical industry environment, such as the development of new drugs and vaccines, new modalities, the adoption of digital transformation (DX) technologies, and expansion into global markets.He also pointed out the current situation of rapidly changing geopolitical trends and increasing uncertainty, emphasizing that regional cooperation—particularly in Asia—is more important than ever, and stated that now is the time to build stronger bonds and strengthen cooperation.

He concluded by expressing his gratitude to all participants and everyone involved in the preparations, and expressed his hope that the 14th APAC Conference would be a highly productive and meaningful event.

Summary of Congratulatory Remarks

In closing, he emphasized the importance of public-private cooperation, expressing his conviction that by working together, we can continue to provide innovative medicines to patients and achieve the shared goal of maintaining world-class standards in Asia’s life sciences sector.

Keynote Speech Summary

Global Health Vision of the Ministry of Health, Labour and Welfare of Japan

PMDA’s Efforts Toward “Tomorrow’s Normal” Together ~with Everyone Around the World~

Regarding the PMDA’s international cooperation in Asia, he touched on the efforts of the PMDA Asia Training Center to date, as well as activities to promote direct communication with regulatory authorities and industry in the Asian region and harmonize regulatory issues through the establishment of the PMDA Asia Office.the concept of “reliance” was explained, and it was stated that efforts to promote this concept would be advanced through cooperation with the World Health Organization (WHO) in the Asian region.

RA (Regulatory Affairs) Session

Initiatives to Promote Reliance Reviews: From the Perspectives of Predictability and Transparency

Chair: Ms. Ayumi Endo, Director, ATC and Bilateral Cooperation Division, PMDA
　　　RA-EWG Leader: Mr. Shinji Hatakeyama

In the RA session on regulation and licensing, the theme “Initiatives to Promote Reliance Reviews: From the Perspectives of Predictability and Transparency” was addressed.The concept of “reliance” introduced here is expected to lead to the rapid delivery of medicines to people around the world by enabling national drug regulatory authorities to cooperate based on mutual trust, thereby advancing the review and approval of medicines efficiently and swiftly.

During the RA session, following an introduction to the concept of reliance recommended by the WHO at the 8th APAC in 2019, participants shared reliance-related guidelines from various Asian economies, presented examples of bilateral reliance where Asian economies reference Japan’s drug approvals,progress on the ASEAN Joint Review promoted by the WHO and ASEAN member states, among other topics aimed at broadening the adoption of reliance reviews.

As mentioned at the beginning of this session, we set the importance of predictability and transparency in the review process through the use of the reliance system as the session’s theme. From the applicant’s perspective, predictability and transparency in the review process are crucial when formulating drug application strategies.By deepening mutual understanding between applicants and reviewers on these issues, we aimed to reaffirm the benefits of reliance-based review and encourage its more active utilization.

Ms. Ayumi Endo, Director of the ATC and Bilateral Cooperation Department at PMDA, was invited to serve as Chair, and Mr. Shinji Hatakeyama, RA-EWG Leader, served as Co-Chair.

First, Mr. Alireza Khadem of the WHO delivered a presentation from a general perspective on the importance of predictability and transparency in reviews under the reliance review system. Next, Ms. Helene Sou of SAPI (Singapore) and Ms. Huyen Do of Pharma Group (Vietnam), representing Asian pharmaceutical industry associations, presented the expectations of applicants.In addition, regarding the initiatives of various Asian regulatory authorities, Ms. Siti Noor Haryani binti Ismail of the Malaysian NPRA and Ms. Worasuda Yoongthong of the Thai FDA shared best practices from their respective agencies.Finally, Mr. Atsushi Kitahara, Director of the PMDA Asia Office, gave a presentation on the PMDA Asia Office’s efforts to promote reliance reviews in Asia.

This was followed by a panel discussion featuring the speakers. Representing the applicant side, KC Wong of Singapore’s SAPI participated as a panelist in place of Mr. Sou and Mr. Do.Moderated by the two chairs, the discussion covered: 1) understanding the “Reliance” framework promoted by the WHO; 2) applicants’ expectations regarding the predictability and transparency of reviews, as well as best practices implemented by Asian regulatory authorities; and 3)key points regarding predictability and transparency in reviews when utilizing the Reliance review system (clarification of processes, communication and mutual understanding, consistency of application documents, support from the WHO and PMDA, etc.). The participants were able to reach a consensus on the key areas to address in order to advance Reliance reviews from the perspective of predictability and transparency.

DA (Drug Discovery Collaboration) Session

Current Status of Microbiome Research in Japan and Asia and Its Applications in Drug Discovery

Chair: Ms. Megumi Ikemori, DA-EWG Leader

With the goal of promoting drug discovery collaboration in Asia—“for the people of Asian countries, Asian nations will cooperate to create innovative pharmaceuticals originating in Asia”—the DA-EWG is advancing (1) the sharing of information on drug discovery leads, (2) the establishment of drug discovery platforms, and (3) the development of the next generation of researchers.

The DA-EWG session continued to focus on microbiome research, as it did in 2024. The microbiome is attracting attention as one of the new modalities in drug discovery research, and active research is underway across Asia—including the establishment of consortia in Japan and other Asian countries.In particular, it has become clear that the gut microbiome influences both health and disease. While it was initially expected to contribute to elucidating disease mechanisms, developing preventive and therapeutic methods, and advancing healthcare, in recent years, several pharmaceutical products have come to market, primarily in Europe and the United States. In Japan, work has also begun on drafting quality guidelines for the approval of fecal microbiota transplantation (FMT).

In this session, chaired by Ms. Megumi Ikemori, Leader of the DA-EWG, three speakers took the stage to discuss the theme “Current Status of Microbiome Research and Its Applications in Drug Discovery in Japan and Asia.”

First, Mr. Atsushi Terauchi of the Japan Microbiome Consortium (JMBC)—a leading figure in domestic microbiome research—and Mr. Jun Kunisawa of the National Institute of Biomedical Innovation, Health and Nutrition (NIBN) took the stage to present “Accelerating Microbiome Research through Industry-Academia Collaboration”and “Challenges and Possibilities of Microbiome Research in Japan,” respectively. Through these presentations, participants reviewed the current state of microbiome research—which is attracting attention as a new modality in drug discovery—and considered its potential for drug development applications, while gaining insights into the ideal form of industry-academia-government collaboration when applying microbiome research to drug discovery.

Finally, Mr. Ryosuke Kuribayashi of the PMDA gave a presentation titled “Regulatory Perspectives on Microbiome-Based Medicines.” Focusing on the PMDA Scientific Committee’s report on the microbiome, he provided insights into regulatory development from a perspective distinct from conventional approaches regarding microbiome-based drug discovery, a new modality.

The DA-EWG intends to continue focusing on the potential and challenges of microbiome-based drug discovery research and to contribute to advancing microbiome research and its application to drug discovery among academic institutions, startups, and pharmaceutical companies across Asia.

e-Labeling Session

Accelerating Efforts Toward e-Labeling—Interoperability with Digital Health Platforms and Utilization as a Healthcare Ecosystem

Chair: Ms. Miki Ota, Director, Safety Information and Planning Management Department, PMDA
　　　Ms. Rie Matsui, e-labeling EWG Leader

The 2025 e-labeling session, themed “Accelerating e-labeling Initiatives—Interoperability with Digital Health Platforms and Utilization as a Healthcare Ecosystem,” featured discussions aimed at further accelerating e-labeling initiatives for patients in the APAC region.

Efforts toward e-labeling in the APAC region have made excellent progress—including the creation and revision of regulations and the issuance of guidance—through cooperation with regulatory authorities. Meanwhile, in Europe and the United States, digital health platforms and Fast Health Interoperability Resources (FHIR)^※） e-labelingの相互運用性が議論され実装に移行しています。本セッションでは、（１）APAC地域のe-labelingの構造化に際し、FHIRの導入に関するベネフィット・リスクを議論し、（２）医療用医薬品の患者向添付文書作成し e-labeling により提供することの重要性を再確認しました。

This session was co-chaired by Miki Ota, Director of the Safety Information and Planning Management Department at PMDA, and Rie Matsui, Leader of the e-labeling EWG.At the outset, Ms. Matsui shared the outcomes of the joint event held in October 2024 between APAC and IMI Gravitate Health in the EU, as well as the first in-person FHIR e-labeling workshop between regulatory authorities and APAC pharmaceutical associations, which took place the day before the 14th APAC meeting.

First, Mr. Craig Anderson, Co-lead of the HL7 VULCAN Electronic Product Information Project, shared insights on the current status and future of FHIR e-labeling in Europe and the United States.Following that, Ms. Worasuda Yoongthong of the Thai FDA and Ms. Mei-Chen Huang of the Taiwan FDA shared updates on the current progress of e-labeling in Thailand and Taiwan, as well as their initiatives regarding FHIR e-labeling.In addition, Ms. Maslinda Mahat of the Malaysian National Pharmaceutical Regulatory Agency (NPRA) presented an interim report on Malaysia’s e-labeling study and outlined future plans.

The panel discussion featured, in addition to the speakers from this session, Ms. YeonHae Han from South Korea’s MFDS,Ms. Nova Emelda of Indonesia’s BPOM, Ms. Maria Cecilia Matienzo of the Philippine FDA, Ms. Annam Visala of India’s CDSCO, and Mr. Ota of the PMDA took the stage, bringing the total number of participants to 10 for a discussion on e-labeling.The panelists shared the current status of e-labeling implementation in their respective markets, followed by a report on the results of a survey conducted in advance of the panel discussion among the eight regulatory authorities participating in the discussion, asking, “In which areas of e-labeling would you like to focus your efforts over the next 3 to 5 years?”The most frequently selected response was whether they would work on structuring e-labeling based on international standards such as FHIR.Furthermore, while discussions and implementation of FHIR are progressing in the pharmaceutical regulatory field, it was noted that since FHIR is an international standard being promoted for adoption in healthcare systems such as electronic prescriptions and electronic health records, incorporating it into e-labeling would also contribute to the broader healthcare ecosystem.On the other hand, some participants expressed the view that use cases need to be discussed to determine how FHIR can be utilized in creating package insert templates and patient information leaflets for that market.

Finally, Mr. Ota of the PMDA summarized the session’s outcomes as follows: 1) Accelerating the implementation of e-labeling in the APAC region for more products and in more markets; 2)2) to consider the adoption of FHIR when structuring e-labeling in the APAC region and to advance discussions to ensure interoperability with digital health platforms and facilitate their utilization; and 3) to create patient-oriented package inserts in the APAC region and promote the provision of drug information via e-labeling.He concluded by stating that discussions will continue to integrate e-labeling as part of the health ecosystem.

MQS Session

Reliance on GMP Inspections

Chair: Mr. Michihiro Imada, Section Chief, Quality Control Division 1 / Section Chief, Certification and Inspection Section, PMDA
　　　Ms. Miyako Maruyama, MQS Task Force Leader

In the MQS session, discussions are held on topics related to manufacturing, quality, and supply in order to achieve the APAC goal of Access to Innovative Medicines (ATIM).

Chaired by Mr. Michihiro Imada, Director of the First Quality Control Division and Director of the Certification and Inspection Division at the PMDA’s Quality Control Department, the session addressed the topic of “Reliance on GMP Inspections,” a concept whose importance is increasingly recognized amid the growing complexity of global supply chains and rapid technological change.

Presentations were given by speakers and panelists from Japan, including Mr. Kentaro Hara of the PMDA’s Quality Control Department; Ms. Kim Mi Hng of the Malaysian NPRA; and Ms. Li Lian Lim of the Singapore HSA. Mr. Hara shared the basic concepts and benefits of reliance in GMP inspections, as well as the PMDA’s activities.Ms. Kim Mi Hng shared information on the status of reliance in Malaysia and the Mutual Recognition Agreement (MRA) in the GMP field among the Association of Southeast Asian Nations (ASEAN) member states.Furthermore, Ms. Li Lian Lim shared information on the status of reliance in Singapore, case studies regarding the MRA in the GMP field concluded between Singapore and South Korea, and GMP collaboration within the Access Consortium.

In the panel discussion that followed, participants discussed the following points based on the content shared in the presentations.

Key points cited for building reliance in GMP inspections included regulatory standardization, regular communication among regulatory authorities, ongoing training, assessment of inspection capabilities, ensuring transparency, and building trust; opinions were shared along with specific examples of initiatives addressing these points.Furthermore, there was a shared understanding of the benefits: in addition to advantages for regulatory authorities—such as avoiding duplicate inspections and improving inspection capabilities at the regional level—companies can reduce resource consumption, and patients can benefit from a shorter approval process while quality is ensured.Furthermore, opinions were expressed regarding the possibility of initiatives within a flexible, non-legally binding framework for GMP inspection reliance, the potential for expanding the application of reliance, and concepts for regional initiatives in Asia; the discussion raised expectations for further developments in the future.

Finally, Chairperson Imada reported the following three points as conclusions:

aUHC (Universal Health Coverage in Asia) Session

Achieving True UHC in Asia

Moderator: Toshihiko Takeda, Boston Consulting Group

Moderated by Toshihiko Takeda of the Boston Consulting Group, this session featured a discussion on the current status of efforts in various Asian countries and regions to address challenges through diverse approaches aimed at achieving UHC.

The event opened with a keynote speech titled “From Health Reform to Global Vision: Building the Future of Healthcare Together” by Mr. Keizo Takemi, former Minister of Health, Labor and Welfare and a member of the House of Councillors.Mr. Takemi provided an overview of Japan’s healthcare reform initiatives, including digital transformation (DX) in healthcare, measures to combat infectious diseases, and efforts to address the uneven distribution of physicians. He advocated for strengthening drug discovery capabilities by incorporating a global perspective, promoting public-private partnerships, establishing a UHC Knowledge Hub, and strengthening cooperation with the Asia-Pacific region.In particular, he emphasized the need to address rising healthcare costs through innovation and to revise the system to ensure access to high-cost treatments. This was followed by presentations by experts from various countries.

From South Korea, Professor Seung-Rae Yu of Dongduk Women’s University presented on “Expenditures on New Drugs by Therapeutic Area in South Korea: International Comparisons and Implications for Policy.”Although South Korea’s spending on new drugs is lower than the Organization for Economic Cooperation and Development (OECD) average, she pointed out the concentration of spending in the cancer sector, advocated for improving the balance of spending across disease areas, and recommended expanding the application of Risk-Sharing Agreements (RSAs) and Exemptions from Pharmaceutical Economic Evaluation (PEE).

From Thailand, Dr. Pattara Leelahavarong of Mahidol University gave a presentation on “The Use of Health Technology Assessment (HTA) to Support Universal Health Coverage (UHC) in Thailand.”Amid limited resources and rapid technological advancements, she explained the importance of HTA in UHC policymaking. She touched on Thailand’s HTA process, cost-effectiveness thresholds, and examples of HTA’s use in price negotiations, emphasizing the need to strengthen collaboration between researchers and policymakers.

From Singapore, Professor Alec Morton of the National University of Singapore presented on “The Role of Private Health Insurance in Singapore’s Health Financing System.”He provided an explanation of Singapore’s health financing system, “S+3M,” and the role of Integrated Shield Plans (IPs)—a form of supplemental health insurance that serves a private insurance function—and discussed the opportunities and challenges related to IPs, the role of Health Technology Assessment (HTA), and the need to promote public understanding of the system.

From Taiwan, Mr. Chung-Liang Shih, Director-General of the National Health Insurance Administration (NHIA) under the Ministry of Health and Welfare, gave a presentation on “Improving Access to Innovative Cancer Treatments.”Against the backdrop of rising cancer mortality rates and treatment costs in Taiwan, he introduced the Taiwan Cancer Drugs Fund (TCDF)—which operates outside the National Health Insurance’s global budget—and emphasized the importance of precision medicine through early detection and the use of real-world data.

During the panel discussion, there was a lively exchange of views on the themes addressed in the individual presentations. In response to rising healthcare costs associated with an aging population, discussions focused on setting spending caps, prioritization using real-world data, the need for balanced reimbursement strategies, and the design and operation of innovative funding mechanisms such as the TCDF.Regarding HTA, participants emphasized the need for a multifaceted perspective—including not only cost-effectiveness but also health benefits, social impact, and financial risk protection—to avoid budgetary constraints on high-cost treatments such as gene therapy.Regarding the role of private insurance, the view was expressed that it is important to design a system that utilizes private insurance to complement public systems, leveraging its ability to reflect individual choice and risk tolerance, while ensuring that it does not deter investment in public systems.

Finally, there was a shared recognition that governments and the pharmaceutical industry should prioritize transparency and coordination to improve access to innovative medicines—by addressing the uncertainties associated with new drugs, conducting post-marketing studies, securing supplementary budgets, and fostering public-private partnerships.

This session provided a valuable opportunity for Asian countries to share challenges and prospects for achieving UHC and to strengthen future cooperation.

Wrap-up

Closing Remarks

Furthermore, through the experience of the COVID-19 pandemic,it has been recognized that “health” is the foundation of society and the economy. He emphasized that while infectious diseases have been addressed, there remain unmet medical needs to which we must still deliver medicines and vaccines; to address these challenges, industry, academia, and government must collaborate, and the pharmaceutical industry must fulfill its responsibility by driving innovation in drug discovery.

In closing, the organizers once again expressed their gratitude to the participants and concluded by stating that they look forward to seeing everyone again at the 15th APAC Conference in 2026.

(RA-EWG: Mr. Shinji Hatakeyama; DA-EWG: Ms. Megumi Ikemori; e-labeling EWG: Ms. Rie Matsui; MQS TF: Ms. Miyako Maruyama;aUHC-EWG: Mr. Osamu Kagawa; Director of International Cooperation: Mr. Yuji Yahiro)

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