In Response to the "11th Asia Pharmaceutical Association Collaboration Conference"

April 6, 2022
Japan Pharmaceutical Manufacturers Association
Chairman Yasufumi Okada

On April 5, 2022, the “11th Asia Partnership Conference of Pharmaceutical Associations (APAC)” was held.
With the aim of realizing its mission to “promptly deliver innovative medicines to the people of Asia,” the 11th APAC adopted the theme “Building a Platform to Deliver Valuable Innovation to the People of Asia for the Next Decade of APAC.” The event was held as a web conference attended not only by representatives of pharmaceutical associations but also by regulatory authorities and academics from Asian countries, including Japan,as well as representatives from regulatory authorities and academia.

Following opening remarks by the President of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and a keynote address by PMDA Chief Executive Yasuhiro Fujiwara, the conference featured a total of five sessions on “Drug Discovery Collaboration,” “Regulatory Affairs and Approval,”“Electronic Package Inserts (e-labeling),” “MQS,” and “aUHC,” and concluded with a special address by Senator Takemi, WHO-UHC Goodwill Ambassador, during which lively discussions and proposals took place.
We are pleased to announce that the agreements reached this year have been compiled as shown in the attached document.

Based on these agreed items, the Japan Pharmaceutical Manufacturers Association will continue to cooperate and collaborate with pharmaceutical associations, government agencies, regulatory authorities, and academia in Asia to further address various challenges.

Abbreviations

IFPMA: International Federation of Pharmaceutical Manufacturers & Associations
PMDA: Pharmaceuticals and Medical Devices Agency (Independent Administrative Institution)
MQS: Manufacturing, Quality Control, and Supply… a term coined by APAC
aUHC: Asian-Universal Healthcare Coverage (Asian universal health coverage system)... a term coined by APAC
WHO: World Health Organization

Outline of the 11th APAC Agreement

Drug Discovery Alliances (DA)

The APAC DA-EWG is working on two initiatives, DSANA and ANPDC, with the goal of promoting drug discovery alliances in Asia.

DSANA: Drug Seeds Alliance Network in Asia

An initiative aimed at promoting the sharing of information on drug discovery seeds in Asia
ANPDC: APAC Natural Product Drug Discovery Consortium

An initiative aimed at promoting the use of natural products in drug discovery and fostering talent

As DSANA and ANPDC continue to make progress each year, we plan to update our future activity strategy. Since the use of Real-World Data (RWD) and Precision Medicine are critically important to the pharmaceutical industry, we will gather information on related initiatives in Asia and incorporate it into our new strategy.

At this year’s DA-EWG session, we invited speakers who are leading initiatives related to the use of RWD and precision medicine to present.Given that 50% of the world’s population lives in Asia, the utilization of RWD and the advancement of Precision Medicine in the region are of paramount importance, though challenges remain. Through the activities of the DA-EWG, we will work to identify these challenges and explore solutions through industry-led initiatives.

Regulations and Approvals (RA)

The Regulations and Approvals team will advance its activities based on a newly formulated concept paper that looks ahead to the next 10 years.

For the sake of people’s health and well-being, we will continue to promote efforts to provide the people of Asia with innovative medical products based on new modalities, not only during emergencies but also under normal circumstances.
We will continue to pursue the regulatory agility cultivated through our experience with the pandemic and propose the establishment of integrated processes and approaches to deliver innovative medical products based on new modalities.

Electronic Packaging Inserts (e-labeling)

We reported that the APAC e-labeling EWG was launched in July 2021 with the participation of 13 Asian pharmaceutical-related organizations and a related organization in Vietnam.

We reported the results of an e-labeling survey covering 12 Asian economies.

While the latest package insert information was accessible as PDF files on regulatory authority websites in nine economies, only two economies used structured formats such as XML, and no economies had interoperability between e-labeling information and other electronic data, such as electronic health records.
Most of the paper package inserts included with products were intended for physicians, and only two economies did not require paper package inserts to be included with products.
Pharmaceutical industry associations in all economies participating in the APAC e-labeling EWG have begun discussions on e-labeling.

An agreement was reached on the APAC e-labeling roadmap.

A position paper on e-labeling initiatives in the Asia region will be prepared in fiscal year 2022. The position paper outlines five steps

(1) Providing the latest package insert information electronically; (2) Attaching barcodes or similar identifiers to outer packaging and linking them to e-labeling to facilitate access to the latest package insert information via smartphone applications and other means, while also making the information easier to read; (3) Eliminating the inclusion of paper package inserts with products; (4) Creating structured electronic package inserts using XML or similar formats;⑤ Adopting interoperability standards to ultimately link and integrate with electronic health records, electronic prescriptions, and other systems, and utilize the information as part of digital health) The paper will be prepared with a focus on
.
We will hold workshops with regulatory authorities regarding e-labeling to share our vision for its implementation.
In Japan, we plan to conduct a pilot test on the use of e-labeling in a format compliant with the HL7 FHIR standard.
Going forward, we will conduct an annual e-labeling survey to track trends in the adoption of e-labeling across the Asian region.

Manufacturing, Quality Control, and Supply (MQS)

Survey Results on GMP Inspections

A survey on the status of GMP inspections in Asia revealed differences in criteria for determining whether to conduct or exempt overseas manufacturing sites from GMP inspections, as well as in requirements for the submission of GMP inspection documents.
We confirmed that we will continue to conduct further research and examine issues related to the efficient implementation of GMP inspections based on PIC/S and MRAs (Mutual Recognition Agreements).

Promoting the Use of Post-Approval Change Management Plans (PACMPs) in Asia

Since the introduction of the PACMP system in Asia and the realization of efficient change management are essential for enabling the early provision of new drugs, we reported on the overview and benefits of the PACMP system, as well as the current situation in Japan.
We will delve deeper into the initiatives necessary to promote the use of PACMP in Asia at the 12th APAC meeting.

Establishing Universal Health Coverage (aUHC) in Asia

The aUHC Task Force aims to provide a forum at the APAC Assembly for discussing initiatives to establish and maintain UHC in Asian countries.

Regarding the impact of the COVID-19 pandemic on UHC in Asian countries, presentations were given from the perspectives of Japan, Taiwan, and the Asian Development Bank on the current status and challenges in various Asian nations.

During the panel discussion, participants debated the challenges and future responses required to achieve and sustain UHC in Asian countries, focusing on the themes of “Resilience” and “Sustainability” from a medium- to long-term perspective for building UHC in Asia.

As lessons learned from the COVID-19 pandemic, the importance of flexible responses by national governments to emergencies—such as maintaining and strengthening healthcare systems tailored to each country’s circumstances and the early approval of vaccines and pharmaceuticals—was reaffirmed.
To achieve sustainable UHC across Asian countries, it is crucial for pharmaceutical companies to continue investing in the Asian market and to promote the elimination of drug lag for innovative medicines; ongoing discussions within the APAC region will be necessary moving forward.