Topics Held the 12th Asian Pharmaceutical Association Conference (APAC) -Speedy delivery of 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, marked its 12th anniversary in 2023. The conference was held in a hybrid online and in-person format for the first time in four years on April 18, 2023, and was attended by over 800 participants from pharmaceutical associations, regulatory authorities and academia from Asian countries and regions including Japan. In order to realize the mission of "Rapid delivery of innovative medicines to the people of Asia," this year's event was held under the theme of "We're all together again -Deliver tenacious power for Access to Innovative Medicine by reaffirming cooperation in Asia," the theme of this year's conference was to demonstrate tenacious power for access to innovative medicine by reaffirming cooperation in Asia.

Introduction

In line with its mission, the Asian Pharmaceutical Associations Alliance Conference (APAC) has focused on resolving regulatory issues related to applications (new drugs and post-marketing) and licensing. However, based on the recognition that it is essential to improve not only regulation but also access to medicines before they reach the hands of patients, APAC has launched the Asian The conference consisted of five sessions, including aUHC Session to discuss Universal Health Coverage (UHC) in Asia starting in 2022.

The presentation materials of the conference are available on the following website. Please refer to this website as well.

https://apac-asia.com/achievements/12th_apac.html

Greetings, congratulatory address, keynote speech

Yasushi Okada, then chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), gave the opening remarks. The following is an excerpt

In preparation for the G7 Hiroshima Summit to be held in May, the Pharmaceutical Manufacturers Association of Japan (PMAJ) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) jointly submitted "Three Recommendations from the Pharmaceutical Industry on the Health Agenda" to the government. One of the three pillars, "Achieving Sustainable Universal Health Coverage (UHC)," calls for discussions on various issues, such as a robust supply chain that can realize stable supply in both peacetime and emergency situations. With regard to "Preparing for the next pandemic," the report recommends the sharing of real-time epidemiological information and the promotion of discussions on international cooperation in drug approval, based on the lessons learned from the COVID-19 pandemic. In addition, in the section on "Coping with Drug Resistance (AMR)," we request and propose a comprehensive and strategic support system in the field of infectious diseases, where it is difficult to make a business case.

The recent pandemic has made it clear to all countries that "if all of humanity is not safe, no one will be safe. We need to further promote global cooperation among pharmaceutical companies, regulatory authorities, and academia, which is the goal of APAC, which has been working under the banner of "bringing innovative medicines to the people of Asia as quickly as possible.

The theme of this year's APAC is "We're all together again - Deliver tenacious power for Access to Innovative Medicine by Deliver tenacious power for Access to Innovative Medicine by reaffirming cooperation in Asia. We will report and discuss critical issues that we need to consider in the pharmaceutical value chain, focusing on "Reliance" and "Agility".

After the opening remarks by President Okada, there was a congratulatory address by IFPMA President Thomas Kuenyi.

In his congratulatory address, he commented on his expectations for Japan's action and leading role in resolving issues related to global health, including UHC, as the chair country of the G7, which was also taken up in the APAC session.

After the congratulatory address by Thomas Kuenyi, a keynote speech was delivered by Yasuhiro Fujiwara, President of the Pharmaceuticals and Medical Devices Agency (PMDA).

In his speech, he spoke about the "international collaboration" in the Corona Disaster, including his efforts as Vice Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), which consists of 36 regulatory authorities, to introduce remote inspections using ICT tools, as well as the efforts of patients and the PMDA to promote the use of ICT tools. He also spoke about the importance of international joint clinical trials in Asia for rapid access to patients.

RA (Regulations and Licensing) Session

In the RA session dealing with regulations and licensing, a panel discussion was held on the theme of "Promoting Efficient Drug Application and Review through Reliance among Regulatory Authorities and Agility in Regulatory Affairs.

The RA session has taken up Reliance recommended by the World Health Organization (WHO) as a topic in the 8th session to be held in 2019, and in the 10th session to be held in 2021, Asian regulators will strongly recognize and support the importance of the "New Normal of Pharmaceutical Regulation" with agility, and The meeting also confirms that the Asian regulatory authorities will strongly recognize and support the importance of a "new normal in pharmaceutical regulation" that demonstrates agility. In response to these discussions, the theme of this year's meeting is to broadly share best practices of Reliance and Agility that have actually been practiced mainly in Asia, and to expand the base of activities to the entire Asia region.

The session chairs were Ms. Junko Sato, PMDA International Director, and Mr. Janis Bernat of IFPMA. To facilitate the panel discussion, each panelist introduced their respective success stories. Ms. Jesusa Joyce N. Cirunay of the Food and Drug Administration (FDA) of the Philippines, through learning from the recent global response to the COVID-19 pandemic, presented examples and the importance of continued compliance and agility promotion with legislation even after a pandemic. Dr. Wen-Yi Hung of Taiwan FDA shared several successful cases of new drug review based on the Japan-Taiwan Corporation Scheme with reference to Japanese approval and PMDA review reports, as well as the advantages and future prospects for review efficiency through the use of Reliance. As an example of the promotion of global inter-authority review collaboration, Dr. Sau (Larry) Lee of the US FDA presented the concept and progress of the post-approval CMC change management joint review pilot promoted by ICMRA. From industry, Mr. Richard Simon R. Binos of the Pharmaceutical Association of the Philippines (PHAP), Ms. Sannie SF Chong of MSD International, and Mr. Masaaki Jianno, a member of the International Committee of the Pharmaceutical Manufacturers Association of Japan, jointly presented a comprehensive research case study on the practice and development of agility in Asia. A comprehensive research case study on the practice and development of agility in Asia was reported.

In the panel discussion that followed, Desi eka Putri of the Indonesian FDA gave an introduction on the state of development of guidance on Reliance in Indonesia, and introduced the following three points as important for the future widespread implementation of Reliance and Agility in Asia, The panelists made lively suggestions.

(1)	In order to promote more efficient and progressive Reliance, the scope should be expanded to include not only new drug review but also post-approval CMC change management as well as inspections of GMP and GCP, etc.
(2)	Applicants need to submit the same information to the authorities conducting the reliance review as they submitted to the reference country in order to ensure that the reference country review report can be evaluated.
(3)	Reliance and agility are concepts and processes that have been recommended in recent years, and it is essential to establish legal frameworks and guidelines based on such frameworks for implementation in each country.

The discussion was meaningful for participants from Asian regulators who will start or promote Reliance Agility in the future.

MQS Session -Promoting the Utilization of the PACMP System in Asia

The MQS (Manufacturing, Quality control and Supply) session discusses topics related to manufacturing, quality and supply in order to achieve APAC's goal of Access To Innovative Medicines (ATIM). The topics are discussed in order to achieve APAC's goal of Access To Innovative Medicines (ATIM). This time, we chose the theme of promoting the use of the Post-Approval Change Management Protocol (PACMP) in Asia, which was introduced at the 2022 APAC meeting, and invited Dr. Wan-Yu Chao of the Taiwan FDA and Dr. Subin Sankarankutty of the Health Sciences Authority (HSA) of Singapore to discuss this topic. Mr. Subin Sankarankutty of the Singapore Health Sciences Authority (HSA) and Ms. Satomi Yagi of the PMDA were invited as panelists for discussion. After the opening declaration of the session by the co-chair, Mr. Shinichi Okuhira of PMDA, Mr. Tomonori Nakagawa, a member of the MQS-Task Force (TF) and a member of the Quality Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), shared the results of the questionnaire regarding post-approval change management in Asia, gave an overview of the PACMP system and explained the purpose of the session. After each panelist reported on the status of implementation of the PACMP system in their country, the session moved on to the panel discussion. During the panel discussion, the panelists provided valuable opinions on (1) what industry associations and international organizations can do to support the use of the PACMP system after its introduction, and (2) efforts to harmonize authorities so that PACMP applications can be submitted under the same package in order to expand the use of the PACMP system. In order to expand the use of PACMP, information from the pharmaceutical industry is needed, and harmonization based on ICH Q12 will improve the efficiency of the review process, reduce duplication of efforts, and enable many patients in Asia to have access to the same quality of medicines.

In closing, Dr. Okuhira summarized the panel discussion by saying that it is necessary to promote the introduction of the PACMP system in each region of Asia in order to deliver benefits to patients and other stakeholders by utilizing this system, which will improve the predictability of post-approval changes and enable the establishment of an efficient supply system, The session concluded.

e-labeling Session

The third session was the APAC e-labeling EWG, which was established in July 2021 and consists of about 40 members from 13 pharmaceutical organizations in the Asian region. In this session, the following reports were first presented as progress against the four activity commitments for 2023 agreed in 2022.

(1)	Finalization and agreement on a position paper for early implementation of e-labeling and harmonization of approaches
(2)	Held the 1st APAC e-labeling Regulators Workshop, attended by 65 participants from 10 Asian regulators
(3)	Planned pilot testing of the use of e-labeling in a format compliant with the HL7FHIR standard, an international standard, by a consortium established in Japan
(4)	Publication of an e-labeling survey of 12 economies in the Asian region.

Next, the following was shared as the content of the position paper.

(1)	Reliable e-labeling platform
(2)	Accessibility options such as GS1, 2D barcodes, etc. and their advantages and disadvantages
(3)	Considerations and considerations for eliminating the inclusion of paper attachments
(4)	Electronic forms of e-labeling and their interoperability with health care systems

The session then recommended that each economy take a step-by-step approach to develop more advanced e-labeling, taking into account available technologies and resources, and reaffirmed the importance of close collaboration among regulators, healthcare professionals, patients, and pharmaceutical companies for the advancement of e-labeling in the Asian region. He reaffirmed the importance of close collaboration among regulators, healthcare professionals, patients and pharmaceutical companies for the advancement of e-labeling in Asia.

Then, Ms. Tomoko Osawa of PMDA, Ms. Yubin Lee of the Korea Food and Drug Safety Administration (MFDS), and Ms. Rosilawati Ahmad of the National Pharmaceuticals Regulatory Agency (NPRA) of Malaysia introduced the current status of e-labeling implementation and pilot programs in their respective economies. In Japan, he shared that access to e-labeling and related documents posted on the PMDA website by reading the GS1 code with an app and the elimination of paper inserts have been started, and that the full transition will take place by the end of July 2023. It was shared that Korea plans to implement a pilot program for e-labeling of ethical drugs in 2023-2024 and will continue to review the revision of the Pharmaceutical Affairs Law. It was shared that Malaysia has established an industry-government task force on e-labeling starting in 2019 and plans voluntary implementation from 2023-2026 based on a survey on e-labeling implementation conducted in 2022.

Next, in addition to the above three participants, the following representatives were also present: Ms. Nova Emelda from the National Drug and Food Regulatory Agency (BPOM) of the Republic of Indonesia, Ms. Po-wen Yang from the Taiwan FDA, Ms. Worasuda Yoongthong from the Thai FDA, Ms. Jesusa Joyce N. Cirunay from the Philippine FDA, and Ms. The APAC e-labeling Summit was held with panelists Nguyen Thanh Lam of the Department of Administration of Medicines (DAV), Ministry of Health, Vietnam.

Indonesia, Thailand, and the Philippines shared their plans for pilot testing and implementation in 2023-2024, and Vietnam shared its view that now is a good time to start discussions on e-labeling implementation. Many economies also shared that they had already had experience with e-labeling of COVID-19 vaccine and its therapeutics prior to the planned pilot project and implementation. In addition, Taiwan, where a pilot is underway, shared issues that have emerged from the current pilot study. In addition, opinions were exchanged on the e-labeling platform, the elimination of paper bundles, and the implementation of HL7FHIR, an international standard, in medical systems, as well as the possibility of introducing e-labeling in the future. The importance of international standardization was recognized as an issue in many economies, and an example was shared that in Japan, the agreement was reached by continuing careful dialogues with stakeholders. The introduction of e-labeling in the HL7FHIR standard needs to be discussed further, although the importance of international standardization was recognized.

At the conclusion of the Summit, Ms. Mimi Choong of HSA Singapore shared the implementation status of e-labeling in Singapore, and expressed her positive opinion that e-labeling is a win-win-win situation for regulators, companies, healthcare professionals, and patients, and is user-friendly. The positive opinions expressed were shared. The session concluded with a discussion on the importance of the position of the package insert in the provision of medical information, the future possibilities of e-labeling, and the importance of further promotion.

DA (Drug Discovery Collaboration) Session

With the goal of promoting drug discovery collaboration in Asia, the DA-EWG has been working on two main initiatives: the Drug Seeds Alliance Network in Asia (DSANA), which aims to promote information sharing of drug seeds in Asia, and the APAC Natural Product Drug Discovery Consortium (APAC NPDC), which aims to promote the use of natural products in drug discovery and human resource development. The APAC Natural Product Drug Discovery Consortium (ANPDC) is a consortium of companies that are working to promote the use of natural products in drug discovery and to develop human resources.

The ANPDC will be active for five years, from 2018 to 2023. Two Japanese pharmaceutical companies will participate in the ANPDC, and each company will collaborate with Thai academia and research institutions to transfer drug discovery screening technologies that will also serve as training for young human resources, and to use these technologies to conduct natural resource screening in Thailand. In 2022, a wrap-up meeting was held in November by relevant organizations in Thailand, and in March 2023, an ANPDC conference was held by the participating countries in this initiative, Thailand, Taiwan, and Japan. In FY2023, the final year of this initiative, we will consider new initiatives and approaches that will allow us to utilize the networking that has been gained among the countries involved through this activity among the three countries.

In the 2023 DA-EWG session, DSANA activities were taken up and three speakers gave presentations. First, Ippei Shimizu, Director of the Division of Cardiovascular Aging Control, National Cardiovascular Center, gave a lecture on the attractiveness of academia seeds in Japan and the difficulties in fostering start-up companies, based on his own experience in creating academia seeds and collaborating with companies. Next, Dr. Tsai-Kun Li, Vice President of Taiwan Biotechnology Development Center (DCB), talked about the efforts of drug discovery collaboration by Taiwanese industry-academia-government and the attractiveness of Japanese academia seeds and start-up companies from an Asian (Taiwanese) perspective. After the three speakers, DSANA member Jun Terauchi joined the panel discussion on drug discovery collaboration and exchanged opinions on the concept of collaboration in drug discovery research. The panelists exchanged opinions on the concept of collaboration in drug discovery research.

Start-ups are playing an increasingly important role in the creation of new drugs. We will continue to identify issues and discuss solutions for drug discovery collaboration in Japan and overseas, including collaboration between academia seeds and startup companies.

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, Mr. Keizo Takemi, a member of the House of Councilors, gave an opening presentation on Financing from a global perspective. Then, from the perspectives of Japan, Singapore, and Thailand, Mr. Teruyuki Katori, Representative Director of Miraiken Garyu, Mr. Jeremy Lim of the National University of Singapore, and Mr. Rungpetch Sakulbumrungsil of Chulalongkorn University, Thailand, spoke about the current status of UHC Financing in their respective countries. The session concluded with a presentation on the current status of UHC financing in each country. At the end of the session, the three speakers and the chairperson, Mr. Toshihiko Takeda, Senior Advisor, Boston Consulting Group, 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 the measures to fill the gap, The participants shared their views on the role of public insurance, what it covers, financial resources, and other issues.

In 2024, the final installment of the three-part series, we will consider taking up the need for public financing of high-cost drugs, etc. from this discussion.

Closing Remarks

At the closing of the meeting, three speakers, Ms. Jesusa Joyce N. Cirunay of the Philippine FDA, Ms. Rosilawati Ahmad of the Malaysian NPRA, and Ms. Shou-Mei Wu of the Taiwanese FDA, gave speeches and thanked APAC for hosting the meeting.

Finally, Mr. Hiroshi Nomura, Vice President of the Pharmaceutical Manufacturers Association of Japan (PMAJ), gave a summary of the day's sessions, including the first face-to-face meeting in four years, what the pandemic has brought, and a review of each session. In particular, he commented on the hybrid format, the first time it has been held in this format, and the benefits of in-depth communication in person and broader communication using online technologies. Pandemics have transformed our society, including online technology. Digital transformation is also a major topic of discussion in the pharmaceutical industry. Collaboration between industry and academia to realize diversified drug targets, joint review and sharing of review results to speed up approval, etc., are bringing about definite changes. At the "12th APAC," we held the meeting in a face-to-face format for the first time in four years, and we strongly sensed the high expectations for Japan's leadership from stakeholders in Asian countries in response to these major changes in the pharmaceutical industry. This was a major milestone in demonstrating Japan's commitment to take the lead in solving healthcare issues in Asia.

( Kazuharu Matsuoka, Director, International Cooperation Department; Takuya Tone,Director, International Affairs Department )

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