On the Occasion of the 10th Conference of Asian Pharmaceutical Manufacturers' Associations
April 14, 2021
Japan Pharmaceutical Manufacturers Association
Chairman: Joji Nakayama
On April 13, 2021, the 10th Asia Partnership Conference of Pharmaceutical Associations (APAC) will be held to realize the mission of "bringing innovative medicines to the people of Asia in a timely manner. The theme of the 10th APAC was "Overcoming COVID-19 and Toward a Decade of New Challenges for Innovation in Asia," and a web conference was held with the participation of not only pharmaceutical associations but also regulatory authorities and academia from Asian countries/regions including Japan.
The conference started with a keynote speech by IFPMA Chief Executive, followed by five sessions on "Regulation and Licensing," "New Drug Access 1 (e-labeling)," "New Drug Access 2 (BCS-based BioWeber)," "Drug Discovery Collaboration," and "Value-based Healthcare (VBH)," with a keynote speech by IFPMA President Yasuhiro Fujiwara (PMDA Chief Executive). The five sessions were held in total, and active discussions and proposals were made.
The following is a summary of this year's agreement.
Based on this agreement, Japan Pharmaceutical Manufacturers Association will continue to cooperate and collaborate with Asian pharmaceutical organizations, government agencies, regulatory authorities, academia, and others to further work on resolving various issues.
Abbreviations
IFPMA: International Federation of Pharmaceutical Manufacturers & Associations
PMDA: Pharmaceuticals and Medical Devices Agency Pharmaceuticals and Medical Devices Agency
BCS: Biopharmaceutics Classification System
VBH: Value-based Healthcare
The 10th APAC Agreed Agenda
Regulations and Approvals (RA)
- Despite the global pandemic, the need for medicines to treat various diseases has not changed, and it is our constant mission to "deliver innovative medicines to the people of Asia in a timely manner.
- This session focused on the theme of "Regulatory Agility in the aftermath of the COVID-19 disaster and its aftermath", and a panel discussion was held with the participation of Asian regulatory authorities and the pharmaceutical industry to discuss what is being done to review new drugs under the current circumstances. The panel discussion was attended by Asian regulators and the pharmaceutical industry.
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Through the discussion, participants strongly recognized the importance of the "New Normal in Regulatory Affairs" in which regulators have exercised their Regulatory Agility.
- Promoting efficiency of new drug review by utilizing Good Reliance Practice bilaterally (Japan and Taiwan) and multilaterally (ASEAN)
- Introduction of an expedited review system for pharmaceuticals in disaster situations (Malaysia)
- Participation in the global COVID-19 pandemic response by the International Collaboration of Medicines Regulatory Authorities (ICMRA) (Japan)
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- APAC will do its best to support regulators to continue the "New Normal in Regulatory Affairs" after COVID-19 is over
Access To Innovative Medicines -1 (Electronic Attachment)
Access To Innovative Medicines; ATIM-1 (e-labeling)
Raise an awareness for benefits of e-labeling in Asia
In Asia, the following e-labeling benefits were agreed upon
- Improved access to up-to-date package insert information, and increased convenience through the use of friendly methods (e.g., adjustable font size, improved readability and search functionality)
- Better treatment outcomes and improved health outcomes through improved understanding of the product among healthcare professionals and patients and enhanced adherence to medication as a result of improved access to up-to-date package insert information
- Elimination of paper product inserts to conserve paper resources and contribute to eco-friendliness, shorten lead time to market, and reduce workload.
- Contribution as part of the digital transformation of the healthcare sector by integrating electronic product inserts with electronic medical records, etc.
Collaboration on e-labeling in Asian region
In the Asian region, regulatory authorities and pharmaceutical industry associations agreed that it is important to collaborate on e-labeling in the region in the future.
- Sharing of e-labeling best practices in the Asian region
- Discussed the establishment of a common e-labeling platform for the Asian region
- Consideration of preparing a position paper on e-labeling initiatives in the Asian region
- Conduct surveys and create a roadmap for the above, as part of efforts to realize the above
Access To Innovative Medicines-2 (BioWeber based on BCS)
Access To Innovative Medicines; ATIM-2 (BCS-based biowaiver)
Exemption from BCS-based bioequivalence studies in post-approval change procedures
- Apply a science and risk-based approach to physical and chemical testing to facilitate waivers of bioequivalence testing in post-approval amendment procedures.
- International guidelines for bioequivalence testing and national guidelines for Asian countries have been issued. However, we observed that there are slight differences among them.
- We hope that the knowledge gained during the development phase will be used to promote bioequivalence study exemptions (ICH M9) based on the Biopharmaceutics Classification System (BCS), which will enable us to provide improved drugs to patients in Asia more quickly.
Drug Discovery Alliances (DA)
- The APAC DA-EWG was established in 2013 with the goal of "bringing innovative medicines to Asian patients through drug discovery alliances in Asia. As a result of past activities, two initiatives, DSANA and ANPDC, have been launched to (1) share information on drug seeds, (2) build a platform for drug discovery collaboration, and (3) develop human resources for young researchers.
DSANA: Drug Seeds Alliance Network in Asia
ANPDC: APAC Natural Product Drug Discovery Consortium - DSANA is an initiative aimed at revitalizing information on drug seeds in Asia. As a pilot project, DSANA is currently working on information sharing between Taiwan and Japan. With the cooperation of the Osaka Chamber of Commerce and Industry, we were able to make solid progress in information sharing between the two countries even in the face of the Corona disaster. The future goal is to expand 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 since achieved significant progress. Two Thai researchers have already completed internships in Japan, and for one, natural product screening has been completed and hit compounds have been found. In addition to on-the-job training, online training will be initiated to develop human resources at Corona Disaster.
- The strategy for activities over the next 10 years will be updated to take into account future trends in drug discovery.
Value-based Healthcare (VBH)
- The VBH Task Force aims to provide a forum for considering primary care enhancement and sustainable healthcare systems at the APAC Assembly.
- We received four presentations titled "Digital Accelerates UHC in Asia," "VBH Initiatives in Thailand," "Value-based Investment for UHC in Asia," and "Considering Pandemic Disaster Data-driven Healthcare.
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In the panel discussion, the panelists discussed the challenges and future of building sustainable healthcare and data-driven medicine in Asia.
- The panelists identified the challenges of balancing access to primary care with productivity improvements in terms of cost.
- After confirming that investment in digital tools is effective in enhancing primary care and UHC, the importance of institutional design and policy push to achieve data-driven medicine was discussed.
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- JPMA has included in its policy recommendations that the pharmaceutical industry, as a leader in the development of science, should create a virtuous circle in order to increase the number of people supporting welfare by extending healthy life expectancy and to stabilize the social security system, leading to sustainable development of society. In the wrap-up, the participants confirmed the recommendations and expressed their hope that digital transformation will lead to improved quality of life for patients and consumers in a data-driven society that is advancing daily, and that APAC, consisting of 13 member associates, will play a role in value creation.