The 11th Asian Pharmaceutical Association Conference (APAC)
April 06, 2022
Japan Pharmaceutical Manufacturers Association, Inc.
Chairman Yasushi Okada
The 11th Asia Partnership Conference of Pharmaceutical Associations; 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 President of IFPMA and President Yasuhiro Fujiwara of PMDA, five sessions were held on "Drug Discovery Collaboration," "Regulations and Licensing," "Electronic Labeling of Drug Information," "MQS," and "aUHC," with a special speech by Mr. Takemi, the WHO-UHC Goodwill Ambassador, from the House of Councilors. 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, 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.
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
WHO: World Health Organization
11th APAC Agreed Agenda
Drug Discovery Alliances (DA)
APAC DA-EWG is working on two measures, DSANA and ANPDC, with the goal of promoting drug discovery collaboration in Asia.
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DSANA: Drug Seeds Alliance Network in Asia
Initiatives aimed at promoting information sharing of drug discovery seeds in Asia
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ANPDC: APAC Natural Product Drug Discovery Consortium
Initiatives aimed at promoting the use of natural products in drug discovery and human resource development
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 very important for 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 challenges and consider solutions to these issues through industry-led initiatives.
Regulations and Approvals (RA)
The Regulations and Licensing Team will promote activities based on a newly developed concept paper that looks 10 years into the future.
- We will continue to promote efforts to provide innovative medical products based on new modalities to the people of Asia, not only in emergencies but also in normal times, for the health and benefit of the population.
- We will continue to pursue the regulatory agility we have developed during the pandemic experience and propose probabilities for integrated processes and approaches to deliver innovative medical products based on new modalities.
Electronic Labeling of Medical Supplementary Information (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 e-labeling information was interoperable 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 for physicians, and there were two economies that did not require paper inserts to be included.
- Pharmaceutical associations from all economies participating in the APAC e-labeling EWG have begun discussions on e-labeling.
The committee agreed on the roadmap for PAC e-labeling.
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A position paper on e-labeling initiatives in Asia will be developed in FY2022. The position paper will be written in 5 steps
(1) Provide up-to-date package insert information electronically, (2) link barcodes, etc. to e-labeling on outer packaging to facilitate access to up-to-date package insert information via smartphone applications, etc. and make them easier to read, (3) eliminate the inclusion of paper-based package inserts in products, and (4) promote the use of structured information such as XML, etc. to facilitate the sharing of information on drug seeds. (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 of this system will focus on the following - A workshop will be held with the regulatory authorities on e-labeling to share the vision for implementation.
- A pilot study is planned in Japan on the use of e-labeling in a format compliant with the HL7FHIR standard.
- An e-labeling survey will be conducted every year to check on the progress of e-labeling in the Asian region.
Manufacturing, Quality Control and Supply (MQS)
Results of Questionnaire on GMP Inspections
- A questionnaire survey on the status of GMP inspections in Asia revealed 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 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) in Asia
- In order to enable early provision of new drugs, it is essential to promote the introduction of the PACMP system in Asia and realize efficient change management.
- We will take a deeper look at the initiatives needed to promote PACMP utilization in Asia at the 12th APAC.
Establishment of Asian Universal Healthcare Coverage (aUHC)
The aUHC Task Force aims to provide a forum at the APAC General Assembly to consider efforts to establish 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 establishment and maintenance of UHC in Asian countries.
- As lessons learned from the COVID-19 pandemic, we confirmed the importance of governments' flexible responses to contingencies, including the maintenance and strengthening of healthcare systems and early approval of vaccines and medicines according to each country's situation.
- 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, which requires continued discussion in APAC.
For inquiries, please contact
Japan Pharmaceutical Manufacturers Association, Public Relations Department
- Phone
- 03-3241-0374