The 14th Conference of the Asian Federation of Pharmaceutical Manufacturers' Associations held on April 23
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 event was held under the mission of "bringing innovative medicines to the people of Asia as quickly as possible. This year, the APAC Conference was again attended by 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 started with a congratulatory address by the President of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), followed by keynote speeches by Mr. Masamika Sakoi, Director of Medical Affairs and Technology, MHLW, and Mr. Yasuhiro Fujiwara, Chairman of PMDA, and then, as last year, five sessions on "Regulation and Licensing," "Drug Discovery Collaboration," "Electronic Labeling of Drug Information," "MQS," and "aUHC. The sessions were attended by active discussions and proposals.
The following is a summary of this year's agreement. Based on this agreement, the JCIA will continue to cooperate and collaborate with Asian pharmaceutical organizations, government agencies, regulatory authorities, and academia to further address various issues.
Abbreviation
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
Attachment: 14th APAC Agreed Agenda
Regulations and Approvals (RA)
Initiatives to Promote Reliance Review - From the Perspective of Predictability and Transparency
- With the understanding of the Reliance promoted by WHO, expectations from the applicant side for predictability and transparency in 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 was also recognized in terms of predictability and transparency of the review process.
Drug Discovery Alliances (DA)
Microbiome research and drug discovery applications in Japan and Asia
- Reviewed the current status of microbiome research, which is attracting attention as a new modality in drug discovery research, and considered 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 development from a different perspective through microbiome drug discovery, a new modality.
Electronic Labeling (e-labeling)
Further acceleration of E-labeling efforts for the benefit of patients
~Interoperability with digital health platforms and their use as a healthcare ecosystem~.
- Accelerate the implementation of e-labeling in the APAC region with more products and more markets.
- Consider the implementation of FHIR in structuring e-labeling in the APAC region, and discuss ways to ensure interoperability between FHIR e-labeling and digital health platforms and to leverage them.
- We will promote the provision of drug information as e-labeling to patients in the APAC region. We will also promote discussions to utilize it as part of the health ecosystem.
Manufacturing, Quality Control and Supply (MQS)
Reliance on GMP Surveillance
- The promotion of GMP survey reliance will support innovation by avoiding duplicate surveys and optimizing the allocation of resources based on risk, thereby creating 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.
Establishment of Asian Universal Health Coverage (aUHC)
Realization of True UHC in Asia
- Utilization of HTA (Health Technology Assessment): The importance of being aware of the differences in HTA implementation in Asian countries and common issues, leading to fair drug pricing, efficient allocation of healthcare resources, and improved access to new drugs was recognized.
- 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 roles and responsibilities 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, financing methods, and criteria for selecting eligible drugs and medical technologies.
The End
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Public Relations Department, Japan Pharmaceutical Manufacturers Association (JPMA)
- Phone
- 03-3241-0374
- Inquiry form
- www.jpma.or.jp/inquiry/