Clinical data required for the approval of pediatric pharmaceuticals in Japan

BMC Pediatrics

Table 1 Extracted information

From PMDA review report	From package insert
Approval date Non-proprietary name Brand name Modality Route of administration Approval classification ^a Administrative incentives (see Table 2) Pediatric clinical studies referred for PMDA review ^b Phase Region (Japan, countries apart from Japan, multi-national studies including Japan) Number of patients (Japanese, non-Japanese) Whether a statistical confirmatory study was conducted or not Whether an investigator-initiated study was conducted or not Discussion points considered for pediatric indications Conditions for approval	Indication Target age Dosage and administration for pediatric patients Precautional statements in the package insert Sect. 9.7 ^c

^aApproval classification; Specifies whether an approval is for a drug with a new active ingredient, an additional indication, a new dose, a new dosage form, or a new route of administration for an existing product
^bInformation on clinical studies included in the review was extracted from Sect. 7 of the PMDA review report. If unavailable, it was sourced from the CTD Module 2.7 disclosed on the PMDA website
^cJapanese package inserts specify precautions for children in this section, categorized by age group
CTD Common Technical Document, and PMDA Pharmaceuticals and Medical Devices Agency

ISSN: 1471-2431