Three years of paediatric regulation in the European Union

Abstract

This is the first analysis of the general impact of the Paediatric Regulation on the development of medicinal products in Europe. Three years after the implementation of the Paediatric Regulation, we were able to identify that the PIPs address the main gaps in knowledge on paediatric medicines. The key objective of the Paediatric Regulation, namely, the availability of medicines with age-appropriate information, is going to be achieved. It is clear also that modifications of the initial proposals as requested by the PDCO are necessary to ensure the quality of paediatric developments. The impact on the number of clinical trials performed remains modest at this point in time, and it will be of high interest to monitor this performance indicator, which will also inform us whether paediatric medicine research takes place in Europe or elsewhere.

Pediatric Pharmaceutical Legislation in the USA and EU and Their Impact on Adult and Pediatric Drug Development

“…As the report is online, more details can be retrieved from it without major efforts. Similar conclusions can be found in a paper by Olski et al [ 12 ], where they present a retrospective analysis of all PIPs submitted to the EMA between 2007 and 2009. The authors' conclusions: "The key objective of the Paediatric Regulation, namely, the availability of medicines with age-appropriate information, is going to be achieved."…”

“…The authors' conclusions: "The key objective of the Paediatric Regulation, namely, the availability of medicines with age-appropriate information, is going to be achieved." [ 12 ] 28.1.1.3 Number of Clinical, Non-clinical and Pediatric…”

Nouveaux médicaments anticancéreux pour les enfants et les adolescents : où en sommes-nous en Europe ?

“…En termes de nombre de PIP, la cancérologie occupe le deuxième rang derrière l'endocrinologie et devant les maladies infectieuses et les maladies cardiovasculaires [14]. PIP en cancérologie a été différé.…”

Changes in Research and Development of Medicinal Products since the Paediatric Regulation

“…In 2011, Olski et al published the first analysis of the general impact of the Paediatric Regulation on the development of medicinal products in Europe. Three years after its implementation an increase in the availability of medicines with age-appropriate information in the next years is shown at least as reported by the high number of PIPs despite the still modest number of clinical trials performed (Olski TM et al, 2011;Davies et al, 2010;Rocchi et al, 2010). Most of the paediatric developments will be performed in therapeutic areas, such as endocrinology, oncology, infectious diseases and cardiovascular diseases, which relates to the economical importance in the adult market, while other areas such as pain management still remains less studied.…”