On the Occasion of the 11th Asian Pharmaceutical Consortium Conference

April 06, 2022
Japan Pharmaceutical Manufacturers Association
Chairman: Yasushi Okada

The 11th Asia Partnership Conference of Pharmaceutical Associations (APAC) was held on April 5, 2022.
The theme of the 11th APAC was "Building a Platform to Deliver Valuable Innovations to the People of Asia for the Next Decade of APAC" in order to realize the mission of "Delivering Innovative Medicines to the People of Asia in a Rapid and Efficient Manner". The conference was held as a web conference with the participation of not only pharmaceutical organization representatives but also regulatory officials and academia from Asian countries and regions, including Japan.

Following the keynote speech by IFPMA President and PMDA Chief Executive Yasuhiro Fujiwara, five sessions were held on "Drug Discovery Collaboration," "Regulations and Licensing," "Electronic Labeling," "MQS," and "aUHC," with a special speech by WHO-UHC Goodwill Ambassador Mr. Takemi The session concluded with a special lecture by Mr. Takemi, a member of the House of Councillors, a WHO-UHC Goodwill Ambassador, followed by lively 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 resolve various issues.

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
WHO: World Health Organization

The 11th APAC Agreed Agenda

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

DSANA: Drug Seeds Alliance Network in Asia (DSANA) is an initiative to promote information sharing on drug seeds in Asia.
ANPDC: APAC Natural Product Drug Discovery Consortium

An initiative to promote the use of natural products in drug discovery and to develop human resources.

As DSANA and ANPDC make progress each year, we will update our strategy for future activities, and as the use of RWD and precision medicine are of great importance to the pharmaceutical industry, we will gather information on initiatives in Asia and apply it to new strategies.

This year's DA-EWG session featured speakers who are leading initiatives related to the use of RWD and Precision Medicine. Since 50% of the world's population lives in Asia, the utilization of RWD and the promotion of Precision Medicine in Asia are extremely important, but challenges also exist. Through the activities of the DA-EWG, we will clarify the issues and consider solutions through industry-led initiatives.

Regulations and Approvals (RA)

The Regulations and Approvals team will promote activities based on a newly developed concept paper looking 10 years into the future.

We will continue our efforts to provide innovative medical products based on new modalities to the people of Asia, not only in emergency situations but also in normal times, for the sake of their health and benefits.
We will continue to pursue the regulatory agility we have developed during the pandemic experience and propose probabilities for an integrated process and approach to deliver innovative medical products based on new modalities.

Electronic Labeling of Attached Documents (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 related organizations in Vietnam.

The results of the e-labeling survey for 12 Asian economies were reported.

Nine economies had access to the latest attachment information from regulatory websites as PDF files, but only two economies used structured formats such as XML, and no economies interoperated e-labeling information with other electronic data such as electronic health records. There were no economies that interoperate e-labeling information with other electronic data such as electronic medical records.
Most of the paper inserts included with the products were attachments for physicians, and there were two economies that did not require paper inserts.
Pharmaceutical associations from all economies participating in the APAC e-labeling EWG have begun discussions on e-labeling.

A roadmap for PAC e-labeling has been agreed upon.

A position paper on e-labeling initiatives in Asia will be developed in FY2022. The position paper is a five-step process

(1) Provide up-to-date package insert information electronically, (2) Link barcodes, etc. on outer packaging to e-labeling to facilitate access to up-to-date package insert information via smartphone applications, etc. and make it easier to read, (3) Eliminate paper-based package inserts for products, and (4) (4) Creation of a structured electronic accompanying document using XML, etc., (5) Incorporation of interoperability standards and eventual linkage and integration with electronic medical records, electronic prescriptions, etc., to be used as part of digital health.
The creation will focus on the following.
Hold workshops with regulatory authorities on e-labeling to share the vision for implementation.
A pilot study on the use of e-labeling in a format compliant with the HL7FHIR standard is planned in Japan.
An e-labeling survey will be conducted every year to monitor the progress of e-labeling in the Asian region.

Manufacturing, Quality Control and Supply (MQS)

Results of Questionnaire on GMP Inspections

A questionnaire survey was conducted on the status of GMP inspections in Asia, and it became clear that there are differences in the criteria for determining whether an overseas manufacturing facility is subject to GMP inspection or exempt from GMP inspection, and in the criteria for requiring submission of GMP inspection documents.
We confirmed that we will continue to conduct further surveys and study issues for efficient GMP inspections based on PIC/S and Mutual Recognition Agreements (MRAs).

Promotion of Post-Approval Change Management Plan (PACMP) Utilization in Asia

Since it is essential to promote the introduction of the PACMP system in Asia and realize efficient change management in order to enable early provision of new drugs, we reported on the overview and merits of the PACMP system and its status in Japan.
We will take a deeper look at the initiatives needed to promote PACMP utilization in Asia at the 12th APAC.

Building Universal Healthcare Coverage (aUHC) in Asia

The aUHC Task Force aims to provide a forum at the APAC Assembly to consider efforts to build and maintain UHC in Asian countries.

The speakers spoke from the standpoints of Japan, Taiwan, and the Asian Development Bank on the current situation and challenges in Asian countries regarding the impact of the COVID-19 pandemic on UHC in Asian countries.

In the panel discussion, under the themes of "Resilience" and "Sustainability" for building UHC in Asia from a mid- to long-term perspective, the panelists discussed the challenges and future measures to realize the building and maintenance of UHC in Asian countries.

As lessons learned from the COVID-19 pandemic, the importance of flexible responses to contingencies by national governments was confirmed, including the maintenance and strengthening of medical systems and early approval of vaccines and medicines according to the situation in each country.
In order to build sustainable UHC in Asian countries, it is important for pharmaceutical companies to continuously invest in the Asian market and promote the elimination of the drug lag of innovative drugs.