Programs Programs relating to the Strategy for Strengthening the Vaccine Development and Production System (SCARDA-related and other programs)

Overview

Pursuant to the Strategy for Strengthening the Vaccine Development and Production System (the “Vaccine Strategy”), AMED aims to prepare for infectious disease emergencies and be able to respond to more virulent mutant strains and infectious diseases that could prove to be a threat in the future. Accordingly, AMED boosts the funding capacity for strategically significant research, initiative for world-leading vaccine research and development centers, and promotes the strengthening of the pharmaceutical startup ecosystem.

List of our Programs

Programs Overview
Program on R&D of new generation vaccine including new modality application With regard to the prioritized infectious diseases stipulated by the government, AMED aims to provide in Japan and overseas safe and efficient vaccines that can make an international contribution in the event of an infectious disease emergency at the earliest possible juncture. Accordingly, in anticipation of an infectious disease emergency, support is provided for (i) infectious disease vaccine development and (ii) research and development into new modalities contributing to vaccine development through integrated and flexible allocation of budgets. (Vaccine Strategy 2.2)
Japan Initiative for World-leading Vaccine Research and Development Centers Aiming for the achievement of Japanese-made vaccines, world-leading research and development centers (a flagships center, centers promising synergetic effects) and institutions to support research and development are set up. At these research centers, we strengthen and promote vaccine-related research aiming to achieve practical results during normal times. (Vaccine Strategy 2.1)
Strengthening Program for Pharmaceutical Startup Ecosystem To solve the shortage of large-scale development funds, this program supports pharmaceutical startup companies’ development and commercialization, especially those engaged in non-clinical study, Phase 1 clinical study, Phase 2 clinical study or exploratory clinical study, on the condition that they also receive funding from venture capital firms registered by AMED specializing in drug development and providing hands-on business management and commercialization support. (Vaccine Strategy 2.6)
Clinical R&D Promotion Program
(Comprehensive Program for Improving Infrastructure to Promote Clinical Application of
Innovative Medical Seeds)
In order to perform a central role in international standard clinical research (pursuant to ICH-GCP), support is being given to Clinical Research Core Hospitals recognized by the Minister for Health, Labour and Welfare under the Medical Care Act, and preparations are underway of an environment for clinical research and trials. Initiatives are pursued to improve a clinical research infrastructure enabling the promotion of the high-quality clinical research and trials required in order for Japan to develop its own innovative drugs and medical devices. These initiatives include the use of academic research organization (ARO) functions, implementation of clinical research and trials securing the safety of research and trial participants, assurance of research quality utilizing medical information, the creation of mechanisms to promote industry-academia collaborations employing startup support divisions, and support for international expansion.
 
*The Program for Establishing Environment of Clinical Trials with Innovative Technologies under this program is linked to the Strategy for Strengthening the Vaccine Development and Production System. (Vaccine Strategy 2.3)

Last updated 10/31/22