よむ、つかう、まなぶ。
【参考資料５】海外で臨床開発が先行した医薬品の国際共同治験開始前の日本人での第Ⅰ相試験の実施に関する基本的考え方について (8 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_41120.html |
| 出典情報 | 医薬品等行政評価・監視委員会（第16回 7／4）《厚生労働省》 |
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参考１
Appendix 2
Basic principles for conducting phase 1 studies in Japanese prior to initiating
multi-regional clinical trials including Japan for drugs in which early clinical
development is preceding outside Japan
December 25, 2023
1. Introduction
The possibility for Japanese to participate in multi-regional clinical trials (MRCTs) may
significantly affect the success or failure of introduction of drugs to Japan in cases
where early clinical development is preceding outside Japan and Japan’s participation in
global development begins to be considered at the start of MRCTs. This document
provides basic principles for the necessities of conducting phase 1 studies in Japanese
prior to initiating MRCTs including Japan for drugs in such a situation to ensure the
safety of Japanese participants in MRCTs and to minimize the disadvantages of patients
caused by the delay of the introduction of the drug to Japan.
In general, it remains desirable that Japan participates from the early phase in clinical
development including phase 1 studies, considering the importance of identifying key
intrinsic and extrinsic ethnic factors early in drug development by obtaining data in
multiple regions and of improving Japan’s capabilities in drug discovery and
development.
2. Basic principles
In general, it is not mandatory to conduct a phase 1 study in each race/ethnicity or
country/region before initiating an MRCT. In principle, an additional phase 1 study in
Japanese is not needed unless it is deemed necessary after assessing whether the
safety/tolerability of the dosage to be evaluated in the MRCTs in Japanese participants
can be explained and the safety is clinically acceptable/manageable based on the data
available prior to Japan’s participation.
On the other hand, it is desirable to consider measures such as including Japan when the
Appendix 2
Basic principles for conducting phase 1 studies in Japanese prior to initiating
multi-regional clinical trials including Japan for drugs in which early clinical
development is preceding outside Japan
December 25, 2023
1. Introduction
The possibility for Japanese to participate in multi-regional clinical trials (MRCTs) may
significantly affect the success or failure of introduction of drugs to Japan in cases
where early clinical development is preceding outside Japan and Japan’s participation in
global development begins to be considered at the start of MRCTs. This document
provides basic principles for the necessities of conducting phase 1 studies in Japanese
prior to initiating MRCTs including Japan for drugs in such a situation to ensure the
safety of Japanese participants in MRCTs and to minimize the disadvantages of patients
caused by the delay of the introduction of the drug to Japan.
In general, it remains desirable that Japan participates from the early phase in clinical
development including phase 1 studies, considering the importance of identifying key
intrinsic and extrinsic ethnic factors early in drug development by obtaining data in
multiple regions and of improving Japan’s capabilities in drug discovery and
development.
2. Basic principles
In general, it is not mandatory to conduct a phase 1 study in each race/ethnicity or
country/region before initiating an MRCT. In principle, an additional phase 1 study in
Japanese is not needed unless it is deemed necessary after assessing whether the
safety/tolerability of the dosage to be evaluated in the MRCTs in Japanese participants
can be explained and the safety is clinically acceptable/manageable based on the data
available prior to Japan’s participation.
On the other hand, it is desirable to consider measures such as including Japan when the