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Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

The European Union’s Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory...

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Detalles Bibliográficos
Autores principales: Rei Bolislis, Winona, Bejeuhr, Gesine, Benzaghou, Fawzi, Corriol‐Rohou, Solange, Herrero‐Martinez, Esteban, Hildebrand, Heidrun, Hill‐Venning, Claire, Hoogland, Hans, Johnson, Craig, Joos, Angelika, Vart, Richard, Le Visage, Geneviève, Kühler, Thomas C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518420/
https://www.ncbi.nlm.nih.gov/pubmed/33411346
http://dx.doi.org/10.1002/cpt.2152
Descripción
Sumario:The European Union’s Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory framework. This paper therefore describes bottlenecks identified by industry that occur during the medicinal development process, including those relating to the scientific advice process, pediatric investigation plan (PIP) development, compliance checks, and study submissions, and offers some considerations and insights to address these. Considerations, which are workable within the current legislative framework, focus on an integrated scientific discussion, optimization of PIP procedures and compliance checks, and an alignment of study‐reporting requirements.