Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

Research output: Contribution to journalJournal articlepeer-review

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Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US. / Christiansen, Helle; De Bruin, Marie L.; Frokjaer, Sven; Hallgreen, Christine E.

In: PLoS ONE, Vol. 17, No. 4, e0266353, 2022.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Christiansen, H, De Bruin, ML, Frokjaer, S & Hallgreen, CE 2022, 'Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US', PLoS ONE, vol. 17, no. 4, e0266353. https://doi.org/10.1371/journal.pone.0266353

APA

Christiansen, H., De Bruin, M. L., Frokjaer, S., & Hallgreen, C. E. (2022). Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US. PLoS ONE, 17(4), [e0266353]. https://doi.org/10.1371/journal.pone.0266353

Vancouver

Christiansen H, De Bruin ML, Frokjaer S, Hallgreen CE. Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US. PLoS ONE. 2022;17(4). e0266353. https://doi.org/10.1371/journal.pone.0266353

Author

Christiansen, Helle ; De Bruin, Marie L. ; Frokjaer, Sven ; Hallgreen, Christine E. / Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US. In: PLoS ONE. 2022 ; Vol. 17, No. 4.

Bibtex

@article{8dbe6eb60d17452abb48917c418f1019,
title = "Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US",
abstract = "Pediatric legislations in the European Union (EU) and the United States (US) have increased medicines approved for use in the pediatric population. Despite many similarities between these frameworks, the EU Paediatric Regulation more often provides regulators with a mandate to require pediatric drug development for novel medicinal products compared to US regulators. If used, this could give rise to differences in the guidance for pediatric use provided for clinicians in the two regions. However, the level of discordance in the guidance for pediatric use between the two regions is unknown. This cross-sectional study compares guidance for pediatric use in the EU Summary of Product Characteristics (SmPC) and the US Prescription Information (USPI) on the level of indications granted for novel medicinal products approved after the pediatric legislations came in to force in both regions. For all indications granted as of March 2020 for novel medicinal products approved in both regions between 2010 and 2018, we compared the guidance for pediatric use in the EU SmPC and the USPI. The guidance for pediatric use differed for 18% (61/348) of the listed indications covering 21% (45/217) of the products, but without the guidance being contradictory. Where guidance differed, an equal share was observed for indications with a higher level of information for pediatric use in one region over the other (49% (30/61) in the US; 51% (31/61) in the EU). The discrepancies in pediatric information could be explained by differences in regulations for 21% (13/61) of the indications. Only a few conditions and diseases (EU n = 4; US n = 1) were observed to cover potential pediatric use outside the approved adult indication. Although the EU Paediatric Regulation more often provides regulators a mandate for requiring pediatric drug development as compared to the US PREA, this was not reflected in the prescription information approved by the two regulatory authorities.",
author = "Helle Christiansen and {De Bruin}, {Marie L.} and Sven Frokjaer and Hallgreen, {Christine E.}",
note = "Publisher Copyright: Copyright: {\textcopyright} 2022 Christiansen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",
year = "2022",
doi = "10.1371/journal.pone.0266353",
language = "English",
volume = "17",
journal = "PLoS ONE",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "4",

}

RIS

TY - JOUR

T1 - Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

AU - Christiansen, Helle

AU - De Bruin, Marie L.

AU - Frokjaer, Sven

AU - Hallgreen, Christine E.

N1 - Publisher Copyright: Copyright: © 2022 Christiansen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2022

Y1 - 2022

N2 - Pediatric legislations in the European Union (EU) and the United States (US) have increased medicines approved for use in the pediatric population. Despite many similarities between these frameworks, the EU Paediatric Regulation more often provides regulators with a mandate to require pediatric drug development for novel medicinal products compared to US regulators. If used, this could give rise to differences in the guidance for pediatric use provided for clinicians in the two regions. However, the level of discordance in the guidance for pediatric use between the two regions is unknown. This cross-sectional study compares guidance for pediatric use in the EU Summary of Product Characteristics (SmPC) and the US Prescription Information (USPI) on the level of indications granted for novel medicinal products approved after the pediatric legislations came in to force in both regions. For all indications granted as of March 2020 for novel medicinal products approved in both regions between 2010 and 2018, we compared the guidance for pediatric use in the EU SmPC and the USPI. The guidance for pediatric use differed for 18% (61/348) of the listed indications covering 21% (45/217) of the products, but without the guidance being contradictory. Where guidance differed, an equal share was observed for indications with a higher level of information for pediatric use in one region over the other (49% (30/61) in the US; 51% (31/61) in the EU). The discrepancies in pediatric information could be explained by differences in regulations for 21% (13/61) of the indications. Only a few conditions and diseases (EU n = 4; US n = 1) were observed to cover potential pediatric use outside the approved adult indication. Although the EU Paediatric Regulation more often provides regulators a mandate for requiring pediatric drug development as compared to the US PREA, this was not reflected in the prescription information approved by the two regulatory authorities.

AB - Pediatric legislations in the European Union (EU) and the United States (US) have increased medicines approved for use in the pediatric population. Despite many similarities between these frameworks, the EU Paediatric Regulation more often provides regulators with a mandate to require pediatric drug development for novel medicinal products compared to US regulators. If used, this could give rise to differences in the guidance for pediatric use provided for clinicians in the two regions. However, the level of discordance in the guidance for pediatric use between the two regions is unknown. This cross-sectional study compares guidance for pediatric use in the EU Summary of Product Characteristics (SmPC) and the US Prescription Information (USPI) on the level of indications granted for novel medicinal products approved after the pediatric legislations came in to force in both regions. For all indications granted as of March 2020 for novel medicinal products approved in both regions between 2010 and 2018, we compared the guidance for pediatric use in the EU SmPC and the USPI. The guidance for pediatric use differed for 18% (61/348) of the listed indications covering 21% (45/217) of the products, but without the guidance being contradictory. Where guidance differed, an equal share was observed for indications with a higher level of information for pediatric use in one region over the other (49% (30/61) in the US; 51% (31/61) in the EU). The discrepancies in pediatric information could be explained by differences in regulations for 21% (13/61) of the indications. Only a few conditions and diseases (EU n = 4; US n = 1) were observed to cover potential pediatric use outside the approved adult indication. Although the EU Paediatric Regulation more often provides regulators a mandate for requiring pediatric drug development as compared to the US PREA, this was not reflected in the prescription information approved by the two regulatory authorities.

U2 - 10.1371/journal.pone.0266353

DO - 10.1371/journal.pone.0266353

M3 - Journal article

C2 - 35377911

AN - SCOPUS:85127530193

VL - 17

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 4

M1 - e0266353

ER -

ID: 306592361