5TH APAC

The Fifth “Asia Partnership Conference of Pharmaceutical Associations (APAC)”:
~ APAC’s continued challenge to create and improve access to innovative medicines ~

The Fifth “Asia Partnership Conference of Pharmaceutical Associations (APAC)” was held on 7th and 8th April with the mission of “To Expedite the Launch of Innovative Medicines for the Peoples in Asia” under the theme of “APAC’s continues challenge to create and improve access to innovative medicines”.

The Fifth APAC Program

Key note Lecture by Prof. Shibuya

Based on the agreements described below, JPMA is determined to overcome the various challenges through cooperation and close collaboration with the pharmaceutical associations, government bodies, regulatory authorities, and academia in Asia.

<Convention Agreement>

1.General

APAC will continue to take on the challenge of improving “Access to Innovative Medicines” (ATIM) in Asia, in cooperation with various stakeholders including the government bodies of each country.
Specifically, we will continue efforts to address the issues of “Regulations and Approvals” and “Drug Discovery Alliances”, and will identify and address additional priority issues related to ATIM, with the aspiration of contributing to the health of the people in Asia.

2.Regulations and Approvals

Implement training on Good Submission Practice as part of Good Registration Management in collaboration with stakeholders for envisioning regulatory convergence in Asia

3.Drug Discovery Alliances

Promote information sharing, networking and capacity building in drug discovery in Asia by making the best use of established APAC DA-EWG platforms.
Pursue drug R&D alliance opportunities to generate innovative medicines from Asia based on common understanding of strengths and features by academia and industry in Asia, as well as challenges that need to be overcome.

4.Other matters

The sixth APAC will be held in Tokyo in 2017 together with the 9th Asia Regulatory Conference (IFPMA).

ATIM Focus

Innovation of new drug is the driving force to fulfil the unmet medical needs. IP, forms the foundation for innovation, and is most important to improve ATIM. In addition to DA & RA, APAC further discuss the possibility to set up a new EWG or project team.

Part1

ATIM_01_Introduction_Hirate

ATIM_02_Mori

ATIM_03_Kim

ATIM_04_Cho

ATIM_05_Um

Part2

ATIM_06_Dato'AISAH

ATIM_07_Bahdar

ATIM_08_Arap-Up_Hirate

Regulation & Approval Session

Progress in 2015

Good registration management roadmap (combination of Good Review Practices and Good Submission Practices) was endorsed in APEC Regulatory Harmonization Steering Committee (RHSC) in February, 2016. As a result, CoE pilot training is planned in November 2016.

Deliverables

APAC agrees
1. To endorse the following RA-EWG deliverables:
 ① Good Registration Management Roadmap
 ② Good Submission Practice Guideline
 ③ Task A Progress report
 ④ Updated Analysis report
2. To implement GRM CoE pilot training (Nov 2016)
3. To promote Task A activities which are to discuss continuously with local regulatory authorities

RA_01 Liu

RA_02 Lim

RA_03 Nagao

RA_04 Panel Discussion

1_APEC_RHSC Endorsed GRM Roadmap

2_APEC_RHSC Endorsed GSubP Guideline

3_Task A Progress Report 2016

4_Analysis Report 2016

Drug Discovery Alliance Session

Deliverables

DAEWG continues:
1. To progress activities based on the following three pillars
 ① information sharing in research area
 ② networking in development area
 ③ capacity building not only for researchers in drug discovery but a structure or a rule in each
   country
2. To initiate activities that can leverage the strength in each country
3. To expand our activities toward Asian countries who have the will to be able to create innovative medicines.

DA_01_Isoda

DA_02_Terashita

DA_03_Damrongchai

DA_04_Okumura

DA_05_Wang