03 June 2020, The Ministry of Health, Labour and Welfare (MHLW) of Japan released a document providing general guidelines for the clinical evaluation of children that can also be evaluated together with adults to further streamline and optimize the clinical development of pharmaceuticals for children. This guideline summarized the points to be noted about the age group and diseases of children that can be evaluated together with adults, outline the study of different diseases in pediatric population, and represent acceptable approaches to those diseases’ clinical evaluation.
Information pertaining to the document could be accessed from the link below:-
成人と合わせて評価可能な小児（10 歳又は 12 歳以上の小児）の臨床評価の留意点について（案）
https://search.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000196844