よむ、つかう、まなぶ。
Global Health Vision of Ministry of Health, Labour and Welfare of Japan (16 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_42939.html |
| 出典情報 | 「厚生労働省国際保健ビジョン」の公表について（8／26）《厚生労働省》 |
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established in 2016, This center has conducted capacity-building activities toward
regulatory harmonization with regulatory authorities especially from Asian countries.
Through bilateral meetings and symposiums with Asian countries under the
government initiatives, Japan has gained trust in its pharmaceutical regulatory system.
As a result, Japan has become as a reference country for the abridged regulatory
pathways3 in various countries, including those in Asia.
For the promotion of clinical development system, since 2020, in order to facilitate
Japan-led international joint clinical trials and accelerate the development and supply
of drugs, the National Cancer Center (NCC) and the National Center for Global Health
and Medicine (NCGM) have established a clinical research and clinical trials
base/network
(“ATLAS” for non-infectious diseases and “ARISE” for infectious
diseases) through local education/training and improving facilities as the “Project for
Establishment of Network of Clinical Research and Clinical Trials in Asia” of the Japan
Agency for Medical Research and Development (AMED). 4 Through strengthening
collaboration between the PMDA Asia Office and the NCC Asian Partnerships Office
in Bangkok, Japan will establish a parallel and cyclical support system, the so-called
drug and medical device development ecosystem, in order to improve the clinical
development environment and to strengthen regulatory capacity, starting with
Thailand.
Through these activities and monitoring regulatory and market trends in other
countries, Japan aims to gradually expand the ecosystem to other Asian and IndoPacific countries.
② Contents
The PMDA will continue to contribute to the capacity building of regulatory
authorities in Asian countries through the PMDA-ATC. Collaborating with the NCC and
NCGM, the PMDA will provide support to regulatory authorities, primarily in Thailand,
through the PMDA Asia Office established in Bangkok in order to strengthen regulatory
capacity based on the needs of stakeholders in the country, including regulatory
authorities, industry, and academia.
The NCC and NCGM will cooperate with the PMDA to support the rapid
3
A regulatory procedure wherein a market authorization decision for a drug is based on the approval
granted by another regulatory authority.
4
The various projects listed as NCGM initiatives in the text will continue to be implemented in the JIHS
after April 1, 2025.
16
regulatory harmonization with regulatory authorities especially from Asian countries.
Through bilateral meetings and symposiums with Asian countries under the
government initiatives, Japan has gained trust in its pharmaceutical regulatory system.
As a result, Japan has become as a reference country for the abridged regulatory
pathways3 in various countries, including those in Asia.
For the promotion of clinical development system, since 2020, in order to facilitate
Japan-led international joint clinical trials and accelerate the development and supply
of drugs, the National Cancer Center (NCC) and the National Center for Global Health
and Medicine (NCGM) have established a clinical research and clinical trials
base/network
(“ATLAS” for non-infectious diseases and “ARISE” for infectious
diseases) through local education/training and improving facilities as the “Project for
Establishment of Network of Clinical Research and Clinical Trials in Asia” of the Japan
Agency for Medical Research and Development (AMED). 4 Through strengthening
collaboration between the PMDA Asia Office and the NCC Asian Partnerships Office
in Bangkok, Japan will establish a parallel and cyclical support system, the so-called
drug and medical device development ecosystem, in order to improve the clinical
development environment and to strengthen regulatory capacity, starting with
Thailand.
Through these activities and monitoring regulatory and market trends in other
countries, Japan aims to gradually expand the ecosystem to other Asian and IndoPacific countries.
② Contents
The PMDA will continue to contribute to the capacity building of regulatory
authorities in Asian countries through the PMDA-ATC. Collaborating with the NCC and
NCGM, the PMDA will provide support to regulatory authorities, primarily in Thailand,
through the PMDA Asia Office established in Bangkok in order to strengthen regulatory
capacity based on the needs of stakeholders in the country, including regulatory
authorities, industry, and academia.
The NCC and NCGM will cooperate with the PMDA to support the rapid
3
A regulatory procedure wherein a market authorization decision for a drug is based on the approval
granted by another regulatory authority.
4
The various projects listed as NCGM initiatives in the text will continue to be implemented in the JIHS
after April 1, 2025.
16