The 10th Asian Pharmaceutical Association Conference (APAC)

April 14, 2021
Japan Pharmaceutical Manufacturers Association, Inc.
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 President and PMDA President Yasuhiro Fujiwara, 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 Health Care (VBH). The five sessions were held in total, and active discussions and proposals were made.
The following is a summary of this year's agreements.

Based on this agreement, JIPMA will continue to cooperate and collaborate with pharmaceutical organizations, government agencies, regulatory authorities, and academia in Asia, and will make further efforts to resolve various issues in the future.

Abbreviation

IFPMA: International Federation of Pharmaceutical Manufacturers & Associations
PMDA: Pharmaceuticals and Medical Devices Agency
BCS: Biopharmaceutics Classification System
VBH: Value-based Healthcare

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 "bring innovative medicines to the people of Asia as quickly as possible".
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.
Through the discussion, we strongly recognized the importance of the "New Normal of Drug Regulation" that the regulatory authorities have worked on with Regulatory Agility.
1. Bilateral (Japan-Taiwan) and multilateral (ASEAN) promotion of new drug review efficiency through Good Reliance Practice
2. Introduction of an expedited review system for pharmaceuticals in disaster situations (Malaysia)
3. Participation in the global COVID-19 pandemic response by the International Collaboration of Medicines Regulatory Authorities (ICMRA) (Japan)
APAC will do its best to help regulators continue the "New Normal in Regulatory Affairs" after the end of COVID-19.

Access To Innovative Medicines -1 (Electronic Attachment)
Access To Innovative Medicines; ATIM-1 (e-labeling)

Raise an awareness for the benefits of e-labeling in Asia

The following benefits of e-labeling in the Asian region were agreed upon

Improve access to the latest package insert information, and increase convenience by utilizing it in a friendly manner (e.g., adjustable font size, etc. to improve readability and search functions)
Improved understanding of the product among healthcare professionals and patients, and better treatment outcomes and health outcomes through 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 the Asian region

Agreed that future collaboration between regulatory authorities and pharmaceutical industry associations on e-labeling in the Asian region is important.

Share of e-labeling best practices in the Asian region
Discussed the establishment of a common e-labeling platform for the Asian region
Consideration of creating a position paper on e-labeling initiatives in the Asian region
Conduct surveys and create a roadmap 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 amendment procedures

Apply a science- and risk-based approach to physical and chemical testing to facilitate exemptions from bioequivalence testing in the post-approval modification process.
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 medicines to Asian patients 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 collaboration in Asia. As a result of past activities, two initiatives, DSANA and ANPDC, have been launched to (1) share information on drug seeds, (2) establish a drug discovery collaboration platform, 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 VBH Task Force will update its activity strategy for the next 10 years, taking into account future drug discovery trends.

Value-based Healthcare (VBH)

The VBH Task Force aims to provide a forum for considering primary care enhancement and sustainable health care systems at the APAC General Assembly.
We received four presentations entitled Digital Accelerates UHC in Asia, VBH Initiatives in Thailand, Value-Based Investments for UHC in Asia, and Pandemic Disaster Data-Driven Medicine.
In the panel discussion, the panelists discussed the challenges and future of building sustainable healthcare and data-driven medicine in Asia.
1. Challenges were identified that should be balanced between access to primary care and productivity improvement in terms of cost.
2. 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.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) has included in its policy recommendations that the pharmaceutical industry, as a leader in the development of science, 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 session, the participants reviewed 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 associations, will play a role in value creation.

For inquiries, please contact

Japan Pharmaceutical Manufacturers Association, Public Relations Department

Phone: 03-3241-0374

Back to 2021 News Release

TOP