The 14th Asian Pharmaceutical Association Collaboration Conference (APAC) Mission: Bringing innovative medicines to the people of Asia as quickly as possible

APAC (Asia Partnership Conference of Pharmaceutical Associations) has been held since 2012 and will be held for the 14th time in 2025. The conference was held on April 22, 2025, and was attended by approximately 700 participants from Japan and abroad, 60% of whom were from overseas. The conference featured five sessions and two keynote speeches, and very active discussions on drug discovery in the drug lifecycle, regulations related to drug application and licensing, and solutions to the challenges of improving access to medicines.

All members of APAC


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

The following is a report on the program of the day.

Opening Remarks

He also noted that APAC's scope of activities will also expand to address the changing environment of the pharmaceutical industry, including the development of new drugs and vaccines, new modalities, the introduction of digital transformation (DX) technologies, and expansion into global markets. He also pointed out that geopolitical trends are rapidly changing and uncertain, and stressed that regional cooperation, especially in Asia, is more important than ever, and that now is the time to build stronger ties and strengthen cooperation.

He concluded by thanking all the participants and all those involved in the preparation, and wished the 14th APAC Congress a very productive and meaningful event.

Abstracts of Congratulatory Remarks

He concluded by saying that public-private cooperation is important, and he believes that by working together we can realize our common goal of continuing to bring innovative medicines to patients and ensuring that Asia's life science sector maintains world-class standards.

Keynote Speech Abstracts

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

PMDA's efforts for "Tomorrow's Normal" together ~with everyone around the world

As for PMDA's international cooperation in Asia, he mentioned the past activities of PMDA Asia Training Center, the establishment of PMDA Asia Office to promote direct communication and harmonization of regulatory issues with regulatory authorities and industries in Asia, and explained the concept of "Reliance". He explained the concept of "Reliance" and stated that the PMDA will promote the concept through cooperation with the World Health Organization (WHO) in the Asian region.

RA (Regulatory Affairs and Licensing) Session

Initiatives to Facilitate Reliance Reviews - From the Perspective of Predictability and Transparency

Chairperson: Dr. Ayumi Endo, Director, ATC & Bilateral Cooperation, PMDA
　　　Mr. Shinji Hatakeyama, RA-EWG Leader

The RA session dealing with Regulatory Affairs and Licensing addressed the theme of "Initiatives to Promote Reliance Review - From the Perspective of Predictability and Transparency". Reliance, which is introduced here, is expected to promote efficient and expeditious drug approval review by promoting mutual trust and cooperation among drug regulatory authorities in different countries, thereby leading to prompt delivery of medicines to people around the world.

In the RA session, after introducing the reliance sconcept recommended by WHO at the 8th APAC in 2019, he shared reliance-related guidelines from Asian economies, introduced case studies of bilateral reliances in which Asian economies refer to Japanese drug approvals, and discussed the WHO and ASEAN The theme of the meeting continues to be to widely disseminate the Reliance Review, including the progress of the ASEAN Joint Review promoted by WHO and ASEAN countries.

As introduced at the beginning of this session, the importance of predictability and transparency in the review process through the use of the Reliance system was set as the session theme. Predictability and transparency of the review process are very important in planning a drug application policy from the applicant's point of view. By deepening mutual understanding between the applicant and the reviewer on these issues, the session aimed to reaffirm the benefits of Reliance Review and to encourage more active use of the system.

Ayumi Endo, Director of ATC and Bilateral Cooperation Department, PMDA, was invited as chairperson, and Shinji Hatakeyama, RA-EWG leader, served as co-chairperson.

Alireza Khadem from WHO gave an overall perspective on the importance of predictability and transparency in the Reliance review process, followed by a presentation on expectations from the applicant side by Helene Sou from Singapore SAPI and Huyen Do from Vietnam Next, Ms. Helene Sou of Singapore's SAPI and Ms. Huyen Do of Vietnam's Pharma Group introduced the expectations from the applicant side on behalf of Asian pharmaceutical industry associations. In addition, Ms. Siti Noor Haryani binti Ismail of NPRA (Malaysia) and Ms. Worasuda Yoongthong of FDA (Thailand) shared the best practices of their respective regulatory authorities in Asia. Finally, Mr. Jun Kitahara, Director of PMDA Asia Office, gave a presentation on PMDA Asia Office's efforts to promote Reliance Review in Asia.

A panel discussion by the speakers followed. Mr. KC Wong of Singapore SAPI participated as a panelist on behalf of Mr. Sou and Mr. Do from the applicant side. The panel discussion was moderated by the two chairs and focused on: 1) understanding of Reliance promoted by WHO, 2) applicant expectations for predictability and transparency of review and best practices implemented by Asian regulatory authorities, 3) key points regarding predictability and transparency of review when using the Reliance Review System (clarification of process, communication and mutual understanding, and application materials), 4) the importance of the Reliance Review System, and 5) the importance of the Reliance Review System in the context of the Japanese market. We were able to reach a consensus on the important points to be addressed in order to promote Reliance Review from the perspective of predictability and transparency of the review process.

DA (Drug Discovery Alliance) Session

Microbiome Research in Japan and Asia: Current Status and Drug Discovery Applications

Chairperson: Ms. Megumi Ikemori, DA-EWG Leader

DA-EWG is promoting (1) information sharing of drug discovery seeds, (2) establishment of a drug discovery platform, and (3) fostering researchers who will lead the next generation, with the goal of promoting drug discovery collaboration in Asia, where "Asian countries work together to create innovative drugs originating from Asia for the benefit of the people of Asian countries.

The DA-EWG session continued to focus on microbiome research in 2024. The microbiome is attracting attention as one of the new modalities in drug discovery research, and is being actively studied in Asia, with consortia being established in Japan and other Asian countries. In particular, the microbiome in the gut has been shown to have an impact on health and disease, and was expected to contribute to the elucidation of disease pathogenesis mechanisms, the development of prevention and treatment methods, and healthcare. In recent years, several pharmaceutical products have been marketed, mainly in Europe and the United States. In Japan, the development of quality guidelines for FMT approval has also begun.

This session was chaired by DA-EWG leader Megumi Ikemori, and three speakers spoke on the theme of "Current Microbiome Research and Drug Discovery Applications in Japan and Asia.

Jun Terauchi of the Japan Microbiome Consortium (JMBC) and Jun Kunisawa of the National Institute of Biomedical Innovation and Nutrition (NIBN), who are leading experts on microbiome research in Japan, took the stage at the beginning of the session to discuss "Accelerating microbiome research through industry-academia collaboration" and "The Challenges and Opportunities for Microbiome Research in Japan". Through their presentations, the participants confirmed the current status of microbiome research, which is attracting attention as a new modality for drug discovery research, and considered its potential for drug discovery applications, and gained insight into how industry-academia-government collaboration should work when microbiome research is used in drug discovery.

Lastly, Mr. Ryosuke Kuribayashi of PMDA gave a presentation on "Regulatory Perspective of Microbiome Drugs," providing insights into the new modality of microbiome drug discovery from a different perspective, focusing on the PMDA Scientific Committee's report on the microbiome.

DA-EWG will continue to focus on the potential and challenges of microbiome drug discovery research, and hopes to contribute to the promotion of microbiome research and its drug discovery applications in academia, start-ups and pharmaceutical companies in Asian countries.

e-labeling session

Accelerating e-labeling initiatives - Interoperability with digital health platforms and use as a healthcare ecosystem

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

The 2025 e-labeling session will be held under the theme of "Accelerating e-labeling Initiatives - Interoperability with Digital Health Platforms and Utilization as a Healthcare Ecosystem," with the aim of further accelerating e-labeling initiatives for patients in the APAC region. The theme of the discussion was to further accelerate e-labeling initiatives for the benefit of patients in the APAC region.

The e-labeling efforts in the APAC region have made excellent progress in collaboration with the regulatory authorities, including the creation/revision of regulations and issuance of guidance. Meanwhile, in the US and Europe, the Digital Health Platform and Fast Health Interoperability Resources (FHIR ^{The first}） 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。

The session was co-chaired by Miki Ota, Director, Safety Information and Planning Administration Department, PMDA, and Rie Matsui, e-labeling EWG leader. At the beginning of the session, Matsui shared the outcomes of the joint event between APAC and the EU's IMI Gravitate Health in October 2024 and the first face-to-face FHIR e-labeling workshop between regulatory authorities and APAC pharmaceutical organizations held the day before the 14th APAC He also shared the results of the first face-to-face FHIR e-labeling workshop with regulators and APAC pharmaceutical organizations held the day before the 14th APAC.

First, Craig Anderson, Co-lead of the HL7 VULCAN Electronic Product Information Project, shared the current status and future of FHIR e-labeling in the US and Europe. Then, Mr. Worasuda Yoongthong from Thailand FDA and Ms. Mei-Chen Huang from Taiwan FDA shared the current progress of e-labeling and FHIR e-labeling initiatives in Thailand and Taiwan. Ms. Maslinda Mahat of NPRA, Malaysia, shared the interim report of the e-labeling study in Malaysia and the future plans.

In the panel discussion, in addition to the speakers of the main session, Ms. YeonHae Han of MFDS, Korea; Ms. Nova Emelda of BPOM, Indonesia; Ms. Maria Cecilia Matienzo of FDA, Philippines; Mr. Annam Visala of CDSCO, India; and Mr. Ota of PMDA from PMDA, and a total of 10 people took the stage to discuss e-labeling. The panelists shared the status of e-labeling implementation in their respective markets, followed by a report on the results of a survey conducted in advance among the eight regulators participating in the panel discussion on the areas of e-labeling they would like to work on in the next three to five years. The most frequently selected answer was whether to work on structuring e-labeling based on international standards such as FHIR. It was also discussed that while FHIR is being discussed and implemented in the pharmaceutical field, its incorporation into e-labeling will also lead to the healthcare ecosystem, as it is a standard that is being promoted internationally for implementation in healthcare systems such as electronic prescriptions and electronic medical records. On the other hand, there was a need to discuss use cases in order to consider how to use FHIR in the creation of templates for market attachments and patient-facing documentation.

Finally, Mr. Ohta of PMDA presented the outcomes of the session, including: 1) Accelerate the implementation of e-labeling in the APAC region with more products and more markets; 2) Consider the implementation of FHIR when structuring e-labeling in the APAC region to ensure interoperability with the digital health platform; and 3) Promote the use of FHIR in the APAC region for the implementation of e-labeling in the APAC region. 3) In the APAC region, create patient-oriented dossiers and promote the provision of drug information as e-labeling. He concluded the session by saying that discussions will be held to utilize the platform as a part of the health ecosystem.

MQS Session

Reliance on GMP Surveys

Chairperson: Dr. Masahiro Imada, Director, Quality Control Section 1 / Director, Verification and Inspection Section, Quality Control Department, PMDA
　　　Mr. Miyako Maruyama, MQS Task Force Leader

The MQS session is discussing topics related to manufacturing, quality, and supply in order to achieve APAC's goal of Access To Innovative Medicines (ATIM).

Chaired by Mr. Rihiro Imada, Director, Quality Control Section 1 / Director, Verification and Inspection Section, Quality Control Department, PMDA, the theme was "Reliance on GMP Surveillance," a topic that is gaining recognition for its importance amidst the increasing complexity of global supply chains and rapid changes in technology.

Speakers/panelists included Kentaro Hara of PMDA's Quality Control Department from Japan, Kim Mi Hng of NPRA, Malaysia, and Li Lian Lim of HSA, Singapore. Mr. Hara shared the basic concept and benefits of GMP survey reliance and PMDA's activities, while Kim Mi Hng shared the status of Malaysia's reliance and the Association of Southeast Asian Nations (ASEAN) Mutual Recognition Agreement (MRA) in the field of GMP. Li Lian Lim shared the status of the Singapore Reliance and the case study of the MRA in the field of GMP between Singapore and Korea, as well as the GMP collaboration in the Access Consortium.

In the panel discussion that followed, the following points were discussed based on the information shared in the lecture.

The key points in building a GMP investigation reliance included standardization of regulations, regular communication among regulators, continuous training, evaluation of investigation capabilities, transparency, and building credibility. In addition to the benefits to the regulatory authorities, such as avoiding duplicate inspections and improving inspection capabilities at the regional level, there is also a common understanding of the benefits to companies in terms of reduced resources, and to patients in terms of shortening the approval process while ensuring quality. There was a common understanding of the benefits. Furthermore, the participants discussed the possibility of a flexible, non-legally binding framework for reliance on GMP surveys, the possibility of expanding the application of reliance, and the concept of an Asian approach to reliance.

Finally, Mr. Imada, Chairperson of the session, reported the following three points in conclusion.

aUHC (Asian UHC) Session

Realizing True UHC in Asia

Chairperson: Mr. Toshihiko Takeda, Boston Consulting Group

This session was moderated by Mr. Toshihiko Takeda of The Boston Consulting Group, who discussed the current status of the various approaches that Asian countries and regions are taking to address the challenges of 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 Councilors. Mr. Takemi gave an overview of Japan's healthcare reform efforts, including medical DX, countermeasures against infectious diseases, and measures to address the uneven distribution of doctors, and advocated strengthening drug discovery capabilities by adopting 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 for institutional review to address the rising cost of healthcare through innovation and to ensure access to high-cost treatments. This was followed by presentations by experts from each country.

From Korea, Dr. Seung-Rae Yu, Professor of Tongdeok Women's University, presented "New Drug Expenditure by Therapeutic Area in Korea: International Comparison and Policy Implications". Although Korea's new drug spending is lower than the OECD average, she pointed out the concentration of spending in oncology, advocated for better spending balance among therapeutic areas, and suggested expanding the application of risk sharing agreements (RSA) and pharmacoeconomic evaluation waivers (PEE).

From Thailand, Dr. Pattara Leelahavarong of Mahidol University presented "Using Health Technology Assessment (HTA) to Support UHC in Thailand. Explaining the importance of HTA in UHC policy making in the context of limited resources and rapid technological progress, she touched on the HTA process, cost-effectiveness thresholds, and examples of HTA use in price negotiations in Thailand, emphasizing the need to strengthen collaboration between researchers and policymakers.

From Singapore, Dr. Alec Morton, Professor of the University of Singapore, made a presentation on "The Role of Private Health Insurance in Singapore's Health Financing System. He explained Singapore's healthcare financing system "S+3M" and the role of Integrated Shield Plans (IP), a complementary medical insurance that plays the role of private insurance, as well as the opportunities and challenges related to IP, the role of HTA, and the need to promote public understanding of the system.

From Taiwan, Chung-Liang Shih, Chief of Health Insurance, Central Health Insurance Agency (NHIA), Ministry of Health and Welfare, made a presentation on "Improving Access to Innovative Cancer Drugs. Against the backdrop of increasing cancer mortality and treatment costs in Taiwan, he introduced the Taiwan Cancer Drugs Fund (TCDF), which operates outside the global budget of the National Health Insurance, and emphasized the importance of early detection and real-world data utilization for precision medicine.

During the panel discussion, there was a lively debate on the topics covered in each presentation. The panelists discussed the need for setting spending caps, prioritization using real-world data, balanced reimbursement strategies, and the design and operation of innovative funding mechanisms such as the TCDF to address the rising cost of healthcare for an aging population. In the case of HTA, he emphasized the need to consider not only cost-effectiveness but also health benefits, social impact, and financial risk protection in order to avoid budget restrictions on expensive gene therapy. Regarding the role of private insurance, he expressed his view that it is important to design a system that does not inhibit the willingness to invest in the public system, while utilizing it in a way that complements the public system and taking advantage of its ability to reflect individual choice and risk tolerance.

Finally, there was confirmation of the common understanding that governments and the pharmaceutical industry should work together to improve access to innovative medicines through transparency and collaboration, addressing the uncertainties associated with new drugs, conducting post-marketing surveillance, as well as through complementary budgeting and public-private partnerships.

This session provided a valuable opportunity for Asian countries to share their 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 was recognized that "health" is the foundation of society and the economy, and that there are still unmet medical needs to which we should deliver medicines and vaccines, not only for infectious diseases, and to solve these issues, industry, academia, and government must cooperate, and the pharmaceutical industry must take responsibility for drug discovery He emphasized that the pharmaceutical industry must fulfill its responsibility by demonstrating innovation in drug discovery.

He concluded by thanking the participants once again and looking forward to seeing them again at the 15th APAC meeting in 2026.

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

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