Top News The 11th APAC (Asian Pharmaceutical Association Conference) was held. -Mission: Rapidly Deliver Innovative Medicines to the People of Asia
Theme: "Building a Platform to Deliver Valuable Innovations to the People of Asia for the Next Decade of APAC

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The Asia Partnership Conference of Pharmaceutical Associations (APAC), which has been held since 2012, will be held for the 11th time in 2022. Continuing from the 10th edition, the conference was held as an online conference on April 5, 2022, with more than 60% of the more than 500 audience members coming from overseas.

Introduction

In accordance 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, but with the recognition that it is essential to improve not only regulation but also access to medicines before they reach the hands of patients so that they can take them, the APAC has now started the Asian The conference was composed of five sessions and two special lectures, including an aUHC Session to discuss Universal Health Coverage (UHC) in Asia.

Presentation materials of the conference are available on our website. If you are interested in the conference, please refer to this page.

https://apac-asia.com/achievements/11th_apac.html

Greetings and congratulatory speeches

Mr. Yasushi Okada, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), gave the opening remarks. The following are excerpts from his speech.

The pandemic of novel coronavirus infection (COVID-19) poses many challenges to the pharmaceutical industry. In 2021, the Japanese government launched the "Strategy for Strengthening Vaccine Development and Production Systems" and the G7 nations agreed to a "100 days mission" to reduce the time required to develop vaccines and treatments to 100 days or less. mission" to reduce the time required to develop vaccines and treatments to 100 days or less. In order to realize this mission, it is necessary for pharmaceutical organizations in each country to cooperate in confronting challenges such as the development of a vaccine development environment utilizing an international clinical trial network, and the manufacturing and procurement of therapeutic drugs as well.

Reform of the drug development environment is particularly urgent in order to realize the APAC Vision. Since its inception, the DA-EWG (drug discovery alliance expert working group) has played a central role in natural product drug discovery in Asia and in the development of Asian drug discovery researchers. The DA-EWG believes that the realization of precision medicine (precision medicine) through the utilization of health and medical big data, such as genome information, will be important in the future, and has included it in this program. We believe that close collaboration among related organizations through APAC will lead to the creation of innovative new drugs and healthcare solutions that will contribute to the extension of healthy life expectancy and economic growth of the people of Asia. We are looking forward to working with you.

After the opening remarks by Chairman Okada, a video congratulatory address by Mr. Thomas Kueni, President of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), was followed by a keynote speech by Mr. Yasuhiro Fujiwara, President of the Pharmaceuticals and Medical Devices Agency (PMDA).

In his speech, he spoke about the importance of "transparency" in the work related to the evaluation of the efficacy and safety of the COVID-19 vaccine in order to obtain broad public understanding, the International Coalition of Medicines Regulatory Authorities (ICMRA), consisting of 36 authorities, and the importance of the "transparency" in the evaluation of the COVID-19 vaccine. He also introduced his efforts as Vice Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), which consists of 36 regulatory authorities, to introduce remote inspections, and to further promote multicenter clinical trials in Asia, which are being promoted mainly by Japanese medical institutions.

DA (Drug Discovery Collaboration) Session

To promote drug discovery collaboration in Asia, the APAC DA-EWG is considering initiatives aimed at information sharing of drug discovery seeds, utilization of natural products for drug discovery and human resource development. More than three years have passed in both initiatives, and we have moved from the stage of creating a mechanism to the stage of utilizing the mechanism. For this reason, rather than sharing the current status of the initiatives, we have selected the themes of real world data (RWD) utilization and precision medicine, which are important for drug development, for APAC in 2022 with a view to selecting new themes for collaboration.

The session opened with a special lecture by Dr. Masayuki Yamamoto, Director of Tohoku University Tohoku Medical Megabank Organization (ToMMo), which was established for the purpose of reconstruction from the Great East Japan Earthquake and has now developed into the largest complex biobank in Japan capable of utilizing medical and genomic information. In his lecture, he gave an overview of ToMMo as well as its potential for precision medicine.

Next, Dr. Pui-Yan Kwok, who is leading the Taiwan Precision Medicine Initiative in Taiwan, introduced the genome analysis of 1 million people using SNP arrays and its use for prevention and treatment. Furthermore, as a government-led initiative, Mr. Tatsuhiko Sunouchi of the Japan International Cooperation Agency (JICA) and Mr. Ugyen Tashi of the Bhutanese government spoke about the establishment of a biobank through bilateral collaboration. After the presentations by the four speakers, Mr. Bruno Jolain of Roche Pharma India joined the second half of the session to discuss the use of RWD and the development of precision medicine. A lively panel discussion was held on the theme of Precision Medicine.

RA (Regulations and Licensing) Session

The RA session was co-chaired by Ms. Junko Sato, Director of International Affairs, PMDA, and Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ). He also introduced a concept paper*1 that outlines the past 10 years of activities and the future direction of activities for the next 10 years. The paper aims to promptly deliver "innovative drugs based on new modalities," which will be increasingly researched and developed, to the people of Asia. In addition, Mr. Takashi Rikugawa, a member of the APAC RA-EWG, introduced a position paper*2 summarizing items that APAC member pharmaceutical organizations should promote dialogue with regulatory authorities in their respective countries with high priority.

The paper was followed by presentations by Jesusa Joyce Cirunay of the Food and Drug Administration (FDA) of the Philippines, Sara Wang of the RDPAC, Vicky Han of Janssen Singapore, and Janis Bernat of the IFPMA. The panel discussion with the four speakers included industry and regulators, and the panelists discussed how the COVID-19 disaster has impacted the approval process for vaccines and other products in many countries. During the discussion, the expectations of both industry and regulators were discussed, but in general it became clear that the elements described in the concept paper and position paper were important. In summary, the chairperson confirmed that the goal of both the public and private sectors is to promote regulatory harmonization/convergence, and that it is important for us, as One Asia, to promote trust building through public-private dialogue. These panel discussions were very informative and hopeful for the RA team as they look ahead to the next 10 years.

e-labeling Session

The third session was that of the APAC e-labeling EWG, which was launched in July 2021. Currently, the APAC e-labeling EWG is a 36-member team of 13 pharmaceutical organizations in the Asian region, and the urgent use of vaccines and therapeutics against COVID-19 has reaffirmed the importance of getting the latest package insert information to the medical community, and the worldwide e-labeling initiative has accelerated.

In this session, we will share the results of the e-labeling EWG activities (e-labeling survey results, roadmap) and discuss the current status and future prospects of e-labeling in the Asian region with the PMDA, Taiwan FDA, Health Sciences Authority of Singapore (HSA), Philippine FDA, National The APAC e-labeling summit was discussed as a panel discussion with six regulators from PMDA, Taiwan FDA, Singapore Health Sciences Authority (HSA), Philippines FDA, Malaysia National Pharmaceuticals Regulatory Authority (NPRA), India Central Drugs Standard Control Organization (CDSCO), and healthcare professionals from National Cancer Center Hospital East as panelists.

Dr. Yoshihiro Aoyagi, National Cancer Center Hospital East, spoke on the current status and issues of electronic labeling of attached documents in Japan from the perspective of a healthcare professional and proposed two issues for the widespread use of e-labeling: 1) improving interoperability and 2) standardization.

Ms. Kaori Ogawa of PMDA's International Division introduced the digitization of package inserts in accordance with the revision of Japan's Pharmaceutical Affairs Law, which will take effect on August 1, 2021. e-labeling, by using XML, makes it possible to immediately utilize information contained in the latest package inserts from other countries and regions for review in their own countries and regions, thereby contributing to faster review. This will contribute to faster review of products in other countries and regions.

Mr. Po-Wen Yang of Taiwan's FDA plans to implement a user-friendly interface for the Drug License Online Search System in the second quarter of 2022, and to develop an XML-based attachment standard that will be structured and standardized in phases, leading to the creation of an e-attachment for all drugs in the near future. The panel also mentioned that the XML-based attachment standard will be developed, structured and standardized step by step, and that in the near future, the electronic version of the attachment will be implemented for all drugs. During the panel discussion, each economy shared their experiences with e-labeling for COVID-19 vaccines and other products, and all economies recognized that the implementation status of e-labeling varies, but it is an important issue as part of digitalization. They also discussed the next challenge to be addressed among the five elements of e-labeling.

Co-chair Junko Sato of PMDA stated that there are many issues to be addressed in the implementation and dissemination of e-labeling, but that by creating a position paper, we can move forward by working together to solve these issues, transcending the boundaries of industry and regulatory authorities. The session concluded with a proposal to continue activities in FY2022, focusing on the development of position papers and opportunities for information sharing (e.g., holding workshops among authorities).

MQS Session

During the MQS session, it was reported that the name of the task force team would be changed from ATIM (Access To Innovative Medicine) to MQS (Manufacturing, Quality control and Supply) to clarify its activities. Next, a report was made on the results of a questionnaire survey on the current status of GMP inspections in Asia, which was conducted as a reference for selecting themes for FY2022, and differences were identified in terms of manufacturing sites subject to GMP inspections, exemption criteria for inspections at overseas manufacturing sites, and exemption criteria for documents and records submitted during inspections. Based on the results obtained, we will continue our investigation and consider the exemption criteria based on the accession to the Pharmaceutical Inspection Cooperative Scheme (PIC/S) and Mutual Recognition Agreement (MRA), and continue our study toward the future to enable efficient implementation of GMP inspections.

Next, we reported on the progress of the utilization of the Post-Approval Change Management Protocol (PACMP) system in Asia, which was selected as the theme for the MQS session to be discussed at APAC in 2023. In order to provide new drugs to Asian patients as quickly as possible, it is necessary to promote the use of the PACMP system in Asia, which is part of the agreement on ICH Q12, and to achieve efficient change management. We reported that we will discuss at the next APAC meeting the initiatives necessary to promote the utilization of the PACMP system in Asia as quickly as possible, with the cooperation and support of each country.

aUHC (Asian UHC) Session

This session will be held in a series of three sessions starting from the 11th APAC with the aim of securing financial resources for new medicines, sustainable supply of basic medicines, and rapid market access for new medicines through knowledge sharing for building social security systems and UHC, in order for Asian countries to continue investing in the introduction of innovative medicines. The series of three meetings will be held starting with the 11th meeting.

This year, Japan, Taiwan, and the Association of Southeast Asian Nations (ASEAN) presented the current status and challenges of UHC to overcome the COVID-19 pandemic, as well as a summary of each country's efforts, particularly in vaccines and therapeutic drugs, followed by a panel discussion. Finally, Mr. Keizo Takemi, a member of the House of Councilors and UHC Goodwill Ambassador of the World Health Organization (WHO), gave a special lecture on UHC from a global and historical perspective at the 11th APAC.

In Lecture 1, Mr. Toshihiko Takeda, Senior Advisor, Boston Consulting Group, spoke on the issue of the drug supply system, which is a challenge for each country in the Corona Disaster, stating that international collaboration will be essential since pharmaceuticals are international products. He emphasized the importance of Japan's role in the future to make the provision system of advanced medical care, regional medical care, and medical care for infectious diseases more robust, and to cooperate with other countries in securing vaccines, accumulating data, and ensuring a certain level of new drugs in the region.

In his second presentation, Mr. Patrick Osewe, Chief of Health Sector, Asian Development Bank, spoke about the low achievement of indicators related to UHC under SDG target 3 in emerging countries in the Asia-Pacific region, the enormous impact of the COVID-19 pandemic on healthcare delivery systems and healthcare financing, and the various challenges that have emerged as a result of the crisis. The presentation also highlighted the various challenges that have emerged as a result of the COVID-19 pandemic. He emphasized the importance of investment by governments in the development of UHC in Asian countries as an opportunity to promote UHC and to prepare for future health crises.

In Lecture 3, Mr. Shi-Chung Chen, Director of Taiwan's Ministry of Health and Welfare, introduced Taiwan's high Service Coverage Index in UHC and factors contributing to Taiwan's good control of the COVID-19 pandemic ("strict immigration control," "voluntary health verification," "vaccination," "maintenance of health care system," and information transparency") were introduced.

In the panel discussion that followed, Dr. Takeda, Dr. Osewe, and Dr. Heather Lin of IRPMA joined the panelists to discuss "Resilience" and “Sustainability" as key points for building UHC after the COVID-19 pandemic. The discussion focused on two themes: "Resilience" and “Sustainability" as points for building UHC after the COVID-19 pandemic.

First, "Resilience" was discussed and various efforts to secure medical care in the aftermath of the COVID-19 pandemic in Asian countries were introduced and discussed. The importance of securing financial resources (financing) by each government was emphasized, and it was concluded that it is important to establish a platform for discussion on the establishment of UHC that is appropriate to the situation in each Asian country. The discussion concluded that it is important to build a platform to discuss the establishment of UHC in accordance with the situation of each Asian country.

In his special lecture, Mr. Takemi introduced UHC from a global perspective and its future prospects: (1) the importance of health care systems from the perspective of security by the United Nations Development Programme (UNDP) and (2) the efforts and commitment of the Japanese government to global health.

In addition, as a response to this pandemic, he touched on the achievements of the launch of COVAX and ACT-A, an international framework for the joint purchase and equitable distribution of COVID-19 vaccine among multiple countries, and pointed out the importance of establishing a permanent mechanism to address the challenges of this time-limited scheme. He concluded by positioning the G7 meeting scheduled to be held in Japan in 2023 as a forum for disseminating information on the establishment of UHC and its realization, and expressed hope for public-private sector coordination and collaboration.

Through this session, Asian countries' experience of the COVID-19 pandemic disaster highlighted the challenges in building UHC, and we were able to reaffirm the importance of building a strong and sustainable UHC. We will further deepen the discussion in the future.

Closing Remarks

In closing, Hiroshi Nomura, Vice President of the Pharmaceutical Manufacturers Association of Japan (PMAJ), summarized the day's sessions.

Pharmaceutical companies must vigorously utilize RWD and digital technologies in R&D to develop innovative drugs. We are increasingly using digital technologies to deliver useful information to healthcare professionals and patients in a more timely manner. The 11th APAC conference concluded with the following words: "We have reaffirmed that digital technology will bring innovation to every stage of the pharmaceutical value chain and contribute to the rapid delivery of new medicines.

( Kazuharu Matsuoka, Director, International Cooperation Department)

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