The 12th Asian Pharmaceutical Association Conference (APAC)" was held.
April 19, 2023
Japan Pharmaceutical Manufacturers Association
Chairman Yasushi Okada
On April 18, 2023, the "12th Asia Partnership Conference of Pharmaceutical Associations (APAC)" will be held to realize the mission of "bringing innovative medicines to the people of Asia in a timely manner" &. The theme of the conference is "Deliver tenacious power for access to innovative medicine by reaffirming cooperation in Asia". The conference was held in Tokyo for the first time in a while, after three years of being forced to hold the conference online due to the Corona Disaster.
Following the opening address by IFPMA President and keynote speech by PMDA President Yasuhiro Fujiwara, five sessions on "Regulations and Licensing," "MQS," "Electronic Labeling," "Drug Discovery Collaboration," and "aUHC" were held, where active discussions and proposals were made.
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.
(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. coined by APAC
Outline of the 12th APAC Agreement
Regulations and Approvals (RA)
It was shared and confirmed that Asia is utilizing a credibility framework in which regulatory authorities reference each other's review results and regulatory agility to facilitate efficient drug submission and review.
It was recommended that these practices be widely adopted by many regulatory authorities in Asia to facilitate the launch of innovative medicines for the Asian population.
Manufacturing, Quality Control and Supply (MQS)
Survey Results on Post-Approval Change Plan (PACMP)
- A survey of APAC member associations related to PACMP revealed that the categories of post-approval changes differ from country to country, that there are differences in the stages of consideration for PACMP implementation, and that there are advantages to using PACMP.
Promoting the Use of PACMPs in Asia
- APAC benefits are expected to include improved predictability of approvals, shortened timelines, and descent of the change categories, and the promotion of the ICH Q12 concept will ensure a global supply of pharmaceutical products of uniform quality.
- First, it was confirmed that it is important to promote the introduction of the system in Asian countries and to expand the system so that many stakeholders can enjoy the benefits.
Electronic Labeling (e-labeling)
An APAC e-labeling position paper was developed and agreed upon for early implementation of e-labeling in Asian countries and for a harmonized approach.
- In promoting e-labeling in the Asian region, the importance of close collaboration among regulators, healthcare professionals, patients, and pharmaceutical companies was reaffirmed.
The 1st APAC e-labeling Regulators' Workshop was held in November 2022 to share the vision for e-labeling implementation. It was agreed to hold the 2nd APAC e-labeling Regulators' Workshop in the future, where position papers will be used to discuss e-labeling using a one-step-ahead international standard (HL7FHIR) that can be used for digital health. It was also confirmed that e-labeling initiatives are important from a sustainability perspective.
- The first workshop was attended by 65 participants from 10 regulatory agencies: BPOM (Indonesia), CDSCO (India), DAV (Vietnam), HSA (Singapore), MFDS (Korea), NPRA (Malaysia), Philippine FDA (Philippines), PMDA (Japan), Taiwan FDA (Taiwan), and Thai FDA (Thailand). Sixty-five participants from the authorities attended.
A pilot study on the use of e-labeling in a format compliant with the HL7FHIR standard, an international standard, will be planned by a consortium launched in Japan.
We reported the results of an e-labeling survey of 12 economies in the Asian region in a paper.
- The e-labeling survey was conducted to confirm the trend of e-labeling penetration in the Asian region over the past two years. The survey will be continued in the future.
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.
- DSANA : Drug Seeds Alliance Network in Asia
An initiative to promote information sharing on drug discovery seeds in Asia - ANPDC : APAC Natural Product Drug Discovery Consortium
Initiatives aimed at promoting the use of natural products in drug discovery and human resource development
In 2022, an ANPDC conference (consortium-wide A wrap-up meeting was held in 2022 to summarize the activities to date. In the future, we will consider new strategies to take advantage of the close relationships gained through these activities.
This year's DA-EWG session featured the activities of DSANA, with lectures on the attractiveness of Japanese academia seeds and the difficulties in fostering startup companies, the attractiveness of Japanese academia seeds and startup companies from an Asian perspective, and Asian collaboration from a larger perspective that involves both. In addition, he spoke about the cooperation in Asia from a larger perspective involving these companies. Start-ups are playing an increasingly important role in the creation of new drugs. We will continue to identify issues and study solutions for drug discovery collaborations in Japan and overseas, including collaboration between academia seeds and startup companies.
Establishment of Asian Universal Health Coverage (aUHC)
The aUHC Task Force aims to provide a forum at the APAC Annual Meeting to consider efforts to build and maintain UHC in Asian countries.
In this session last year, the importance of finance was raised as an issue regarding efforts to build and maintain UHC in Asian countries. This year's session focused on the theme of finance, with speakers from Japan, Thailand, and Singapore discussing the current situation and challenges in their respective countries.
In the panel discussion, the following points were mainly discussed on the theme of "Definition of UHC in each country" and "Finance to realize UHC" to address the issues and future responses in each country to realize UHC, since the economic and social conditions in each Asian country are different.
- The participants discussed the definition of UHC in each country, the role of public insurance in realizing UHC, and the appropriate scope of public insurance.
- Discussions were held on the necessary measures to bridge the gap between UHC and the current situation from the perspective of finance.
For inquiries, please contact
Public Relations Department, Japan Pharmaceutical Manufacturers Association (JPMA)
- Phone
- 03-3241-0374
- Inquiry form
- www.jpma.or.jp/inquiry/