Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union.
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
29
05
2019
accepted:
13
11
2019
pubmed:
24
12
2019
medline:
26
5
2021
entrez:
24
12
2019
Statut:
ppublish
Résumé
Many prescription drugs approved for adult use lack pediatric labeling information, resulting in their off-label use in children. Drug regulatory authorities have developed legal and regulatory frameworks to promote pediatric drug development. However, the current state of pediatric indication approval and quality of efficacy evidence, which forms the basis of regulatory approvals, is unknown. Here, we analyzed novel therapeutics approved in Japan, the United States, and the European Union during 2005-2014 to investigate the timing and frequency of pediatric indication approval, and characterized the design of pediatric studies supporting regulatory approval. We found that the United States and European Union experienced a higher frequency of supplemental indication approval in pediatrics based on better-designed studies than Japan. The speed and efficiency of pediatric drug development will improve by coordinating pediatric studies on an international basis. The results also implied the necessity for a robust system of postmarketing monitoring of pediatric efficacy and safety.
Substances chimiques
Prescription Drugs
0
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
985-994Informations de copyright
© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
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