Drug Evaluation Committee Briefing Session on the Alliance for Research in Southeast and East Asia (ARISE)" on April 2, 2025

Mar 17, 2025

The Academic Research Organization (ARO) Alliance for Southeast and East Asia (ARISE; Alliance for International Collaborative Clinical Research in Southeast and East Asia) will be established by the National Center for Global Medical Research (NCGM.) in 2021. ARISE will promote high quality clinical trials for research and development of medical products for infectious diseases in Asia through international collaboration with clinical trial networks (14 sites in 6 Asian countries), and will be a leading organization in the global pandemic preparedness. ARISE aims to play a leading role in the fight against pandemics.
In the past, ARISE has supported the development of in vitro diagnostic products for malaria and COVID-19 in Asian countries. More recently, ARISE has been involved in conducting intervention studies for medical devices and in an intervention study for the prevention of mother-to-child transmission of hepatitis. Currently, as a project utilizing the ARISE network, we are planning to conduct a study using genome sequencing of AMR strains. Based on this data, we are considering clinical trials aimed at applying for drug approval using international research support funds such as GARDP. Furthermore, we hope to collaborate with pharmaceutical companies in the future through feasibility studies and investigator-initiated clinical trials aiming for regulatory approval in Asia.
We have also started collaboration with the PMDA Asia office and are visiting regulatory authorities in ARISE-related countries, as we are building relationships with the health ministries in each country, Communication support is also available. By continuing our activities in a coordinated manner during normal times, we aim to serve as a platform for the prompt issuance of vaccines and therapeutics from Japan in the event of a contingency for emerging and re-emerging infectious diseases.

  1. (1)
    Date and Time: April 2, 2025 (Wednesday), 11:00 a.m. - 12:00 p.m.
  2. (2)
    Method: Webinar (advance registration required)

If you wish to participate, please register by 11:00 a.m. on April 2 at the registration site below. Anyone is welcome to participate.

  • As of December 2023
    Registration is now closed. Thank you for your registration.

Program (tentative)

  • Opening remarks 5 min.
  • Overview of ARISE, progress, and collaboration with pharmaceutical companies (Daisuke Tokita, International Trials Department, Clinical Research Center, National Institute for Health Risk Management) 35 min.
  • Q&A 15 min.
  • Closing remarks 5 min.

Briefing Materials

What is ARISE?

ARISE (ARO Alliance for Southeast & East Asia) is an international joint clinical research alliance in Southeast and East Asia led by the National Institutes of Health and Crisis Medicine. ARISE was launched with support from the Japan Agency for Medical Research and Development (AMED) program "Project for Establishment of Clinical Research and Clinical Trial Network in Asia" from 2021.

ARISE's vision is to become Asia's leading and reliable network of AROs collaborating to promote and optimize the implementation of clinical trials for infectious diseases, and it is working toward the following three goals (2024-2025).

  1. 1
    Promotion of participation and implementation of clinical trials on infectious diseases in collaboration with industry
  2. 2
    Ensuring integrity, safety, ethics and quality of investigator-initiated clinical trials
  3. 3
    Building resources and capacity for conducting clinical trials

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