On the occasion of the "14th Asian Pharmaceutical Manufacturers Association (APMA) Joint Conference
April 23, 2025
Japan Pharmaceutical Manufacturers Association
Chairman Hiroaki Ueno
On April 22, 2025, the 14th Asia Partnership Conference of Pharmaceutical Associations (APAC) was held with the mission of "bringing innovative medicines to the people of Asia in a timely manner. This year's conference was held under the mission of "bringing innovative medicines to the people of Asia as quickly as possible. This year, the APAC Conference again welcomed approximately 700 participants from pharmaceutical associations, regulatory authorities, and academia from Japan and other Asian countries and regions as speakers and audience members, and meaningful discussions were held.
The conference featured a congratulatory address by the President of IFPMA, a keynote speech by Mr. Masamika Sakoi, Director-General of Medical Affairs and Technology, MHLW, and Mr. Yasuhiro Fujiwara, PMDA Chief Executive, followed by five sessions on "Regulations and Licensing," "Drug Discovery Collaboration," "Electronic Labeling of Drug Information," "MQS," and "aUHC," as last year's conference, and lively discussions were held. The sessions were attended by active discussions and proposals.
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, and academia, and will make further efforts to solve 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.
aUHC: Asian-Universal Healthcare Coverage.
Annex: The 14th APAC Agreed Agenda
Regulations and Approvals (RA)
Initiatives to Facilitate Reliance Reviews - From the Perspective of Predictability and Transparency
- Under the understanding of Reliance promoted by WHO, expectations from the applicant side for predictability and transparency of review and best practices implemented by Asian regulators were shared.
- The applicant and reviewers shared a common understanding of the key points regarding predictability and transparency of review when using the Reliance system (e.g., clarity of process, communication and mutual understanding, consistency of application materials, support by WHO and PMDA, etc.).
- The importance of the Reliance System in terms of predictability and transparency of the review process was also recognized.
Drug Discovery Alliances (DDA)
Current Microbiome Research and Drug Discovery Applications in Japan and Asia
- We will review the current status of microbiome research, which is attracting attention as a new modality in drug discovery research, and consider its potential for drug discovery applications.
- To gain insight into the nature of industry-academia-government collaboration when microbiome research is utilized in drug discovery.
- To consider how to approach regulatory formulation and guideline creation from a different perspective through microbiome drug discovery, a new modality.
Electronic labeling of accompanying documents (e-labeling)
Further accelerate e-labeling efforts for the benefit of patients
～ Interoperability with digital health platforms and use as a healthcare ecosystem
- Accelerate e-labeling implementation in the APAC region with more products, more markets.
- In the APAC region, FHIR will be considered in structuring e-labeling, and discussions will be held to ensure interoperability between FHIR e-labeling and digital health platforms, and to leverage this interoperability.
- We will promote the provision of drug information as e-labeling to patients in the APAC region. We will also discuss how to utilize this information as a part of the health ecosystem.
Manufacturing, Quality Control and Supply (MQS)
Reliance on GMP Surveys
- The promotion of GMP investigation reliance will support the realization of innovation by avoiding duplicate investigations and optimizing the allocation of resources based on risk, thereby generating resources for both authorities and companies.
- To promote GMP survey reliance, it is essential to build mutual understanding and trust among authorities through communication, training, and assessment. This process is expected to maintain a high level of GMP in each country.
- The realization of GMP survey reliance will contribute to early approval by conducting GMP assessments with minimal resources and time. This will enable the early provision of high quality medicines to patients.
Building Universal Health Coverage (aUHC) in Asia
Realization of true UHC in Asia
- Utilization of HTA (Health Technology Assessment): Recognizing the differences in the status of HTA implementation and common issues in Asian countries, the committee recognized the importance of being aware that HTA can lead to fair drug pricing, efficient allocation of healthcare resources, and improved access to new drugs.
- Role of private medical insurance: Private medical insurance may be used as a measure to cope with the aging of the population and rising medical costs associated with new drugs and advances in medical technology. However, it will be important to clarify the role and responsibility of private medical insurance in ensuring equitable access to healthcare.
- Establishment of a fund: Clarify the purpose and significance of establishing a fund to overcome financial obstacles in accessing innovative drugs. The possibility and challenges of establishing a fund in other Asian countries were discussed, with reference to the Taiwanese case regarding the fund's management structure, funding methods, and criteria for selecting eligible drugs and medical technologies.
For inquiries, please contact
Public Relations Department, Japan Pharmaceutical Manufacturers Association (JPMA)
- Phone
- 03-3241-0374
- Inquiry form
- www.jpma.or.jp/inquiry/