In Response to the “10th Asia Pharmaceutical Association Collaboration Conference”
April 14, 2021
Japan Pharmaceutical Manufacturers Association
Chairman: Joji Nakayama
On April 13, 2021, the “10th Asia Partnership Conference of Pharmaceutical Associations;Asia Partnership Conference of Pharmaceutical Associations (APAC)” was held on April 13, 2021, with the aim of realizing its mission to “promptly deliver innovative medicines to the people of Asia.” For this milestone 10th conference, the theme was set as “Overcoming COVID-19 and Embarking on a Decade of New Innovation in Asia.” The event was held as a web conference attended not only by representatives of pharmaceutical associations but also by regulatory authorities and academics from Asian countries, including Japan,as well as representatives from regulatory authorities and academia.
Following opening remarks by the President of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and a keynote speech by PMDA Chief Executive Yasuhiro Fujiwara, the conference featured a total of five sessions on “Regulation and Approval”“Access to New Drugs 1 (e-labeling),” “Access to New Drugs 2 (BCS-Based Bio-Waivers),” “Drug Discovery Collaboration,” and “Value-Based Healthcare (VBH),” during which lively discussions and proposals took place.
We are pleased to announce that this year’s agreed-upon items have been compiled as shown in the attached document.
Based on these agreed items, the Japan Pharmaceutical Manufacturers Association will continue to cooperate and collaborate with pharmaceutical associations, government agencies, regulatory authorities, and academia in Asia to further address various challenges.
Abbreviations
IFPMA: International Federation of Pharmaceutical Manufacturers & Associations
PMDA: Pharmaceuticals and Medical Devices Agency (Independent Administrative Institution)
BCS: Biopharmaceutics Classification System
VBH: Value-based Healthcare
Key Points of the 10th APAC Agreement
Regulations and Approvals (RA)
- Despite the global pandemic, the need for treatments for various diseases remains unchanged, and “delivering innovative medicines to the people of Asia promptly” is our unwavering mission.
- In this session, we addressed the theme of “Regulatory Agility during and after the COVID-19 pandemic” and held a panel discussion with participants from Asian regulatory authorities and the pharmaceutical industry to explore the initiatives currently being taken regarding new drug reviews under the current circumstances
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Through the discussion, we gained a strong appreciation for the importance of the “new normal in regulatory affairs,” which regulatory authorities have addressed by demonstrating regulatory agility.
- Promoting the streamlining of new drug reviews through the use of Good Reliance Practice at the bilateral (Japan-Taiwan) and multilateral (ASEAN) levels
- Introduction of a rapid drug review system during disasters (Malaysia)
- Participation in the global response to the COVID-19 pandemic through the International Cooperation on Medicines Regulatory Affairs (ICMRA) (Japan)
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- As APAC, we will do our utmost to support regulatory authorities in continuing the “New Normal of Pharmaceutical Regulation” even after the COVID-19 pandemic subsides
Access to Innovative Medicines-1 (Electronic Package Inserts)
Access to Innovative Medicines; ATIM-1 (e-labeling)
Raise awareness of the benefits of e-labeling in Asia
In the Asia-Pacific region, consensus was reached on the following benefits of e-labeling
- Improved access to the latest package insert information and enhanced convenience through user-friendly features (such as adjustable font size, improved readability, and search functions)
- Achieving better treatment outcomes and improved health through enhanced understanding of products among healthcare professionals and patients—resulting from improved access to the latest package insert information—and strengthened medication adherence
- Conservation of paper resources and contribution to environmental sustainability by eliminating paper package inserts; shorter time-to-market; and reduced administrative workload
- Contributing to digital transformation in the healthcare sector by integrating electronic package inserts with electronic health records and other systems
Collaboration on e-labeling in the Asian region
It was agreed that future collaboration on e-labeling among regulatory authorities and pharmaceutical industry associations in the Asian region is important.
- Sharing best practices for e-labeling in the Asian region
- Discussion on establishing a common e-labeling platform for the Asian region
- Consideration of drafting a position paper on e-labeling initiatives in the Asian region
- As part of efforts to achieve the above, conducting surveys and developing a roadmap
Access to New Drugs-2 (BCS-based Biowaiver)
Access to Innovative Medicines; ATIM-2 (BCS-based biowaiver)
Exemption from Bioequivalence Testing Based on BCS in Post-Approval Change Procedures
- Promote the exemption from bioequivalence testing in post-approval change procedures by applying physicochemical testing based on a science- and risk-based approach.
- International guidelines for bioequivalence studies and national guidelines in Asian countries have been issued. However, we have identified slight differences between them.
- We hope that by utilizing insights gained during the development phase and promoting the exemption from bioequivalence studies based on the BCS (Biopharmaceutics Classification System) (ICH M9), improved medicines can be made available to patients in Asia more quickly.
Drug Discovery Alliances (DA)
- The APAC DA-EWG was established in 2013 with the goal of “delivering innovative medicines to Asian patients through drug discovery alliances in Asia.”As a result of its activities to date, the group has launched two initiatives—DSANA and ANPDC—and has been working on (1) sharing information on drug discovery leads, (2) building a drug discovery alliance platform, and (3) developing young researchers.
DSANA: Drug Seeds Alliance Network in Asia
ANPDC: APAC Natural Product Drug Discovery Consortium - DSANA is an initiative aimed at revitalizing the exchange of information on drug discovery leads in Asia. As a pilot project, we are currently working on information sharing between Taiwan and Japan. With the cooperation of the Osaka Chamber of Commerce and Industry, we have been able to ensure steady progress in information sharing between the two countries even amid the COVID-19 pandemic. Our future goal is to expand these information-sharing efforts to other Asian countries.
- The ANPDC was established in 2018 with the goal of utilizing natural products for drug discovery and has achieved significant progress since then. Two Thai researchers have already completed internships in Japan, and one of them has finished screening natural products and identified hit compounds.In addition to on-site training, we plan to launch online training programs to foster talent during the COVID-19 pandemic.
- Taking future trends in drug discovery into account, the organization plans to update its strategic plan for the next 10 years.
Value-Based Healthcare (VBH)
- The VBH Task Force aims to provide a forum at the APAC Assembly to discuss the enhancement of primary care and sustainable healthcare systems.
- Four presentations were given under the titles “Digital Technology Accelerates UHC in Asia,” “VBH Initiatives in Thailand,” “Value-Based Investment for UHC in Asia,” and “Data-Driven Healthcare in the Pandemic Era.”
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The panel discussion addressed the challenges and future of sustainable healthcare and the development of data-driven healthcare in Asia.
- The panel identified the challenge of balancing access to primary care with cost-effectiveness.
- After confirming that investment in digital tools is effective in enhancing primary care and UHC, the discussion turned to the importance of institutional design and policy support for realizing data-driven healthcare.
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- The JPMA has included in its policy proposals that the pharmaceutical industry, as a driver of scientific advancement, should create a virtuous cycle to extend healthy life expectancy, thereby increasing the number of people able to support the welfare system, stabilizing the social security system, and contributing to the sustainable development of society.In the wrap-up, the proposals were reaffirmed, and participants expressed their hope that, in an ever-evolving data-driven society, digital transformation would lead to improved quality of life (QOL) for patients and the general public, and that APAC—comprising 13 member associates—would continue to play a role in creating value.