"The 13th Asian Pharmaceutical Manufacturers' Association Conference" held on
April 24, 2024
Japan Pharmaceutical Manufacturers Association
Chairman Hiroaki Ueno
On April 23, 2024, the "13th 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 conference welcomed not only pharmaceutical associations, but also regulatory authorities and academia from Asian countries and regions, including Japan, as speakers and audience members.
Following the opening address by the new President of IFPMA and keynote speech by PMDA President Yasuhiro Fujiwara, the conference held a total of five sessions on "Regulation and Licensing," "Drug Discovery Collaboration," "Electronic Labeling of Drug Information," "MQS," and "aUHC," where active discussions and proposals were made, as in the previous year. The sessions were followed by a discussion and recommendations. The conference was followed by a special speech by Mr. Keizo Takemi, Minister of Health, Labor and Welfare, making it a very productive conference.
We are pleased to announce the following summary of this year's agreement.
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.
(Abbreviations)
IFPMA: International Federation of Pharmaceutical Manufacturers & Associations
PMDA: Pharmaceuticals and Medical Devices Agency
MQS: Manufacturing, Quality Control and Supply -- a term coined by APAC
aUHC: Asian-Universal Healthcare Coverage -- a term coined by APAC coined by APAC
Outline of the 13th APAC Agreement
Regulations and Approvals (RA)
The regulatory review and approval of medicines under the ASEAN Joint Assessment demonstrated the efficiency of multilateral cooperation in drug review.
It was shared that WHO has made a significant contribution to the ASEAN Joint Assessment.
Industry can expect the benefit of efficient review across multiple countries by submitting their products to the ASEAN Joint Assessment.
Drug Discovery Alliances (DA)
With the goal of "creating innovative drugs originating in Asia for the benefit of the people of Asian countries through cooperation among Asian countries," the DA-EWG has been working to (1) share information on drug discovery seeds, (2) build a drug discovery platform, and (3) foster researchers who will lead the next generation.
This year's DA-EWG session focused on microbiome research in Asia.
Microbiomes have been attracting attention in drug discovery research, and it has become clear that the microbiome in the gut, in particular, has an impact on health and disease, and is expected to contribute to the elucidation of disease mechanisms, the development of prevention and treatment methods, and healthcare.
Microbiome research is also being actively pursued in Asian countries; a microbiome consortium was launched in Taiwan along with Japan in 2017. In the session, microbiome consortium leaders from Japan and Taiwan took the stage to introduce microbiome research and drug discovery in Asia, as well as its future prospects.
We expect that collaboration among researchers from academia, startups and pharmaceutical companies in Asian countries will accelerate microbiome research and its drug discovery applications.
Electronic Labeling (e-labeling)
Promote the adoption of e-labeling in more markets, more pharmaceutical companies, and more products for the benefit of patients in Asian countries.
- The year 2023 saw significant progress in the e-labeling initiative, with guidance issued in many markets in the Asia region, although it has been a great year for the APAC e-labeling EWG since its establishment in 2021, In many markets, pharmaceutical companies will be implementing it voluntarily, and we will continue to promote the adoption of e-labeling by more pharmaceutical companies and in more products for the benefit of patients.
Further discussion on the introduction of structured e-labeling using international standards for use in digital health
- In the Asian region, discussions on structured e-labeling using international standards have just started in a limited number of markets. Further discussion on the introduction of structured e-labeling using international standards will be held at the 3rd APAC Regulators' Workshop. In addition, many markets in the Asian region are discussing the introduction of HL7FHIR into the healthcare system, and this will be taken into consideration in the future.
Discuss the importance of promoting the introduction of patient-oriented e-labeling (patient health literacy-oriented drug information)
- In the Asian region, patient-oriented labeling has been created in only about 30% of the markets. Therefore, the current introduction of e-labeling is mainly for healthcare professionals and not for patients.
Continue implementation of e-labeling survey
- We have conducted an e-labeling survey and confirmed the trend of e-labeling diffusion in the Asian region over the past three years. We will continue the survey in the future.
Manufacturing, Quality Control and Supply (MQS)
Share useful case studies to ensure supply of medicines during the COVID-19 pandemic.
Need to expedite the process of adding a second supplier to ensure safety and quality to prepare for emergency situations.
Continued consideration of recommended measures to achieve a stable supply chain for pharmaceuticals, in coordination with international harmonization efforts.
Establishment of Asian Universal Health Coverage (aUHC)
The aUHC Task Force aims to provide a forum at the APAC General Assembly to consider efforts to build and maintain UHC in Asian countries.
Last year, this session focused on the theme of finance, with presentations on the current status and challenges in each country from the perspectives of Japan, Thailand, and Singapore.
The objective of this year's session is to enable basic medical care to be covered by public insurance and to overcome drug lag and drug loss.
In this session, he concluded that public insurance is important to achieve UHC and that the use of private insurance to supplement public insurance should be an option.
- Understand the gap between the ideal of UHC and the current situation, as well as the differences in the situation in each region.
- Confirmed that the role of private insurance is an option to complement public insurance and not a major player in UHC.
For inquiries, please contact
Public Relations Department, Japan Pharmaceutical Manufacturers Association (JPMA)
- Phone
- 03-3241-0374
- Inquiry form
- www.jpma.or.jp/inquiry/