Top News The 13th Asian Pharmaceutical Association Conference (APAC) was held. -Mission: To rapidly deliver innovative medicines to the people of Asia

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The Asia Partnership Conference of Pharmaceutical Associations (APAC), which has been held since 2012, will be held for the 13th time in 2024. This year's conference was held in a hybrid format on April 23 under the theme "We reaffirm the APAC's mission and fulfill it for patients in Asia. Of the more than 600 participants at the conference, approximately 60% were from overseas. The conference consisted of five sessions and one special lecture on issues related to drug discovery, regulatory submission and approval, and improving access to medicines during the drug lifecycle.

Introduction

Presentation materials of the APAC conference are available on the APAC website. Please refer to this page as well.

APAC: https: //apac-asia.com/achievements/13th_apac.html

The following is a report on the day's program.

RA (Regulations and Licensing) Session

In the RA session dealing with regulations and licensing, Mr. Naoyuki Yasuda, Executive Officer of PMDA, and Mr. Janis Bernat of IFPMA were invited as session chairs, and the theme of the session was "Promoting Further Reliance Scheme through International Cooperation". Reliance, introduced here, refers to the efficient and expeditious promotion of drug approval review through mutual trust and cooperation among drug regulatory authorities of different countries, which is expected to lead to the prompt delivery of medicines to people around the world.

In the RA Session, we have promoted discussions including case studies such as bilateral Reliance, in which Asian countries refer to Japanese drug approvals, since we adopted the introduction of the Reliance concept recommended by the World Health Organization (WHO) in the 8th session in 2019. Therefore, in 2024, in order to further develop the Reliance Concept, we adopted as a session topic the importance of efforts to promote drug approval review jointly by multiple countries under international cooperation. As for the joint review of medicines across multiple countries in Asia, the ASEAN Joint Review promoted by WHO and the Association of Southeast Asian Nations (ASEAN) countries has accumulated experience in multiple drug reviews since 2017, and shared its efforts with drug regulatory authorities and the pharmaceutical industry in Asian countries participating in APAC This was a good opportunity.

Ms. Marie Valentin of WHO, who plays a central role in promoting ASEAN Joint Review, and Ms. Azuana Ramli, Head of ASEAN Joint Review Coordination Group and Malaysian authority, presented a broad perspective on the background, achievements, and future prospects of ASEAN Joint Review. In addition, Ms. Ria Christine Siagian of the Indonesian authorities and Ms. Jesusa Joyce N. Cirunay of the Philippine authorities shared specific examples of new drug review and approval in their countries using the ASEAN Joint Review.

In the panel discussion that followed, Mr. KC Wong of the Singapore Pharmaceutical Association was invited to participate as a representative of the pharmaceutical industry, and all speakers facilitated a meaningful discussion. The outcome of the lively panel discussion was that the review and approval of drugs under the ASEAN Joint Review clearly demonstrated the efficiency of multilateral cooperation in drug review, and that the pharmaceutical industry can expect the benefits of efficient multi-country review by submitting its products to the ASEAN Joint Review. The session participants were able to confirm with the session participants as a whole that It was also widely known that WHO has made a significant contribution to the establishment and promotion of the ASEAN Joint Review. Once again, this was a very important session, which was a reminder of the significance of our efforts to promote Reliance in Asia.

DA (Drug Discovery Collaboration) Session

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 to "create innovative drugs originating from Asia through cooperation among Asian countries for the benefit of the people of Asian countries.

Until 2023, we will continue to promote information sharing of drug discovery seeds mainly in Asia (Drug Seeds Alliance Network in Asia, DSANA) and the utilization of natural products for drug discovery and human resource development (Natural Product Drug Discovery Consortium (APAC), Natural Product Drug Discovery Consortium (NPDC)). Although the ANPDC completed its five-year activities in FY2023, two Japanese pharmaceutical companies participated in this project, which aims to develop young human resources and transfer screening technologies in collaboration with research institutions in Thailand, as well as to promote the use of natural products in drug discovery and human resource development. DSANA will continue to promote information sharing and bi-directional drug discovery collaboration between Taiwan and Japan, targeting academia, start-ups, and pharmaceutical companies.

DA-EWG has decided to take up microbiome research starting in 2024. The microbiome is being actively studied in Asia, with consortia being established in Japan and Taiwan. In particular, it has become clear that the microbiome in the gut has an impact on health and disease, and is expected to contribute to healthcare by elucidating the mechanisms of disease onset and developing prevention and treatment methods.

During the DA-EWG session at the APAC conference, Mr. Jun Terauchi, Chair of the Steering Committee of the Japan Microbiome Consortium (JMBC) and President of the Taiwan Microbiota Consortium (TMC), who are the leaders of the microbiome consortiums in Japan and Taiwan, respectively, and Despite the short 30-minute session, many questions were asked by the audience after the presentations, showing the high level of attention paid to microbiome research. The audience was very interested in the microbiome research.

DA-EWG will continue to focus on the microbiome's potential and challenges in drug discovery research and 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

The e-labeling session, titled "Asian e-labeling strategy for digital health - what we should do now and what we should do in the future," discussed the current and future e-labeling initiatives in the Asian region.

At first, the following three points were reported as progress against the commitment of activities in 2023 agreed upon in 2023.

1) Number of reports and countries from which data was obtained	The APAC e-labeling EWG has contributed to e-labeling initiatives in the Asia region, with e-labeling guidance issued in eight markets by 2023.
2)	The 2nd APAC e-labeling Regulators' Workshop was held in October 2023 with over 140 participants from 11 regulators to share e-labeling progress, best practices and challenges.
3)	That a consortium established in Japan has developed a pilot study plan for the use of e-labeling in a format compliant with HL7 FHIR, an international standard for the electronic exchange of medical information, and is working to make it a reality.

Then, Mr. Takayuki Okubo, Director of the Office of Safe Use Promotion, Drug Safety Division, Pharmaceuticals and Lifestyle Health Bureau, Ministry of Health, Labour and Welfare, Japan, shared Japan's efforts in medical digital transformation (DX) and provision of drug information to patients. Ms. Azuana Ramli of the Malaysian authorities explained that they will issue guidance on e-labeling in April 2023, and will continue to implement e-labeling on a voluntary basis until December 31, 2026, after which they will consider implementing e-labeling again. Mr. Po-Wen Yang of the Taiwanese authorities explained that they are promoting the digitization, standardization, and paperless implementation of e-labeling, and that the XML implementation of e-labeling has been completed on the Taiwanese authorities' platform by the end of 2023; the status of the paperless pilot that started in 2022 He also stated the status of the paperless pilot that started in 2022, and that HL7 FHIR is scheduled to be implemented for e-labeling in 2024. Rita Endang of the Indonesian Authority explained that guidance for the pilot will be issued in September 2023 and that the 2D barcodes will be scanned with the Indonesian Authority's Track and Trace app and available as a PDF from the Indonesian Authority's website. Yeonhae Han from the Korean authorities reported that the Pharmaceutical Affairs Law was amended in January 2024 to allow electronic labeling to be provided for designated drugs, and that e-labeling guidance was issued in December 2022 and a pilot study is underway.

In addition to the above five panelists, Jesusa Joyce Cirunay from the Philippine authorities, Worasuda Yoongthong from the Thai authorities, and Luong Thu Vinh from the Vietnamese authorities joined the panel to discuss which areas of e-labeling to address in the next three to five years. The panelists discussed which areas of e-labeling will be addressed in the next three to five years. The Philippines has experience in implementing smart labeling equivalent to e-labeling as a response to the corona disaster, and expressed a desire to issue implementation guidelines by early 2025. In Vietnam, they would like to create a roadmap, conduct pilot tests, and use the results for implementation to revise the law. In Taiwan, it was mentioned that the Ministry of Health and Welfare recommends HL7 FHIR and plans to introduce HL7 FHIR for e-labeling from the viewpoint of interoperability. On the other hand, Thailand is planning to migrate to XML by the end of FY2024, but it is important to introduce international standards similar to those of healthcare systems and to promote international collaboration in the future, he explained. In addition, Malaysia commented that patients are the most important stakeholders in the e-labeling initiative.

The session concluded with the following four summary points.

1) Number of reports and countries from which data was obtained	Many of the e-labeling initiatives in the Asian region are being implemented by pharmaceutical companies on a voluntary basis, and the company intends to promote the adoption of e-labeling by more pharmaceutical companies and for more products in the future.
2)	To promote discussion on structured e-labeling using the international standard HL7 FHIR, with a view to its introduction.
3)	To discuss the importance of promoting the introduction of e-labeling for patients in the future, since only about 30% of the market has created patient-oriented labeling.
4)	To continue to conduct the e-labeling survey and check the trend of e-labeling diffusion.

MQS Session

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

The COVID-19 outbreak in 2019 has had a significant impact on the pharmaceutical supply chain. While a stable supply of medicines is the responsibility of pharmaceutical companies to patients in need of medicines, events that disrupt the functioning of the supply chain, such as the spread of infectious diseases or natural disasters caused by climate change, are expected to occur in the future. A survey of APAC members and pharmaceutical association member companies on the challenges of maintaining supply chains in the event of an emergency revealed that securing a second supplier was the most important issue. Therefore, MQS held a discussion on the topic of expediting the process of adding a second supplier.

As speakers/panelists, we invited Mr. Nur'Ain Shuhaila from the Malaysian authorities, Mr. Chaiporn Pumkam from the Thai authorities, and Mr. Shinichi Okudaira from PMDA in Japan, who presented useful case studies from Malaysia and Thailand to maintain drug supply under the COVID-19 epidemic. The panelists introduced useful case studies from Malaysia and Thailand, and from PMDA, the PQ KMS initiative of the International Coalition of Medicines Regulatory Authorities (ICMRA).

Following the case studies, the panel discussion focused on (1) measures that can be considered by regulators to expedite the regulatory process in emergency situations when changes in raw material manufacturing sites may affect the quality of drug products, (2) ICMRA's efforts, and (3) the most significant challenges to ensuring a stable supply in emergency situations and their The panelists provided valuable input on the challenges and effective regulatory and industry measures. It was suggested that determining the data needed for adding a second supplier based on risk could speed up the process.

Finally, Mr. Shinichi Okuhira of PMDA reported the following three points in summary and the session was closed.

1) Number of reports and countries from which data was obtained	Useful case studies were shared to secure drug supply during the COVID-19 pandemic
2)	To prepare for emergencies, the process of adding a second supplier needs to be expedited to ensure safety and quality
3)	Continued consideration is needed to achieve a stable supply chain for pharmaceuticals, while linking the recommended measures with international harmonization efforts

aUHC (Asian UHC) Session

This session is planned as a series of three sessions starting in 2022 under the theme of aUHC (Asia Universal Health Coverage), with the aim of improving access to innovative medicines in Asian countries by sharing knowledge on how to build social security systems and UHC in each country. The first meeting will be held in 2022.

In the first session in 2022, the importance of the resilience and sustainability of UHC, the importance of which was reaffirmed by the Corona disaster, was discussed, and it was concluded that the investment of necessary financial resources (Financing) is important to realize this.

In the second session in 2023, under the theme of Financing, the participants discussed the gap between the current state of UHC and the ideal state of UHC based on the different situations in each country and region, as well as measures to fill the gap, and shared their views on the role of public insurance, coverage, and financial resources.

In 2024, the final session of the three-part series, the discussion theme was "Should or can all drugs be covered by public insurance?

Mr. Toshihiko Takeda, Senior Advisor, Boston Consulting Group and Policy Counselor, Health and Medical Strategy Office, Cabinet Secretariat, gave an opening presentation on the importance of publicly insured healthcare services and the "drug lag/loss" problem in Japan, which is being considered as a problem to be solved. He also introduced the efforts of the "Conceptual Council for Prompt Delivery of the Latest Medicines to the Public through Enhanced Drug Discovery", which is a study to solve the drug lag/loss problem in Japan.

Following that, Mr. Muhammed Anis Bin Abd Wahab, ProtectHealth Corporation, Malaysia, and Mr. Cheng-Hua Lee, Deputy Director General, National Health Insurance Administration (NHIA), Taiwan, gave presentations. Cheng-Hua Lee, Deputy Director General of the National Health Insurance Administration (NHIA) in Taiwan, shared the status of UHC achievement in their respective regions, as well as the current situation and problems in health insurance financing.

Afterwards, three speakers discussed the need for public insurance, what options are available when public insurance does not cover the costs, and the possibility of using private insurance. They talked about the challenges of the current situation where most health care services are covered by taxes from the public, but not all medicines are covered by public insurance. They also concluded that there are many issues regarding the use of private insurance as an option when public insurance does not cover the cost, such as premiums, and problems with enrollment in low-income groups, which make it difficult to consider private insurance as an effective option. In addition, there are concerns that government cost containment will lead to a decrease in investment from the pharmaceutical and healthcare industries, which will result in the inability to provide better medical care to the general public. In this context, there was also a discussion on the need for deregulation to encourage investment from the pharmaceutical and healthcare industries.

At the end of the session, it was noted that financial resources are necessary to provide better medical care to the public, including pharmaceuticals, and that Japan's efforts in public insurance can serve as a reference for other Asian countries and regions.

（In the second part of his presentation, he explained the organizational and operational plan to establish five divisions (General Crisis Management Bureau, General Research and Development Support Bureau, Medical Care Provision Support Bureau, Human Resource Development Bureau, and System Infrastructure Development Bureau) in April 2025, centering on the General Crisis Management Bureau.

He explained that collaboration among academia, start-ups, and pharmaceutical companies is essential for innovative new drug development, and that (3) will be promoted in light of the current insufficient introduction of cluster campuses in Japan at a time when the horizontal division of labor is observed worldwide, and finally (4) will be implemented in collaboration with the World Bank and WHO to promote the development of Finally, as (4), he explained that a "UHC Knowledge Hub" is planned to be established in Japan in 2025 to support knowledge and experience of UHC and human resource development of financial and health authorities in low- and middle-income countries in cooperation with the World Bank and WHO.

( Yuji Yahiro, Director, International Cooperation Department)

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