Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products

Ceci, Adriana; Felisi, Mariagrazia; Catapano, Mariana; Baiardi, Paola; Cipollina, L.; Ravera, S; Bagnulo, S.; Reggio, S.; Rondini, G

doi:10.1007/s00228-002-0511-0

Cited by 34 publications

(3 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[819] The degree of licensed vaccines for children is far better because of certain economic refund. [20] Quite alarming results from our research are existence of nine therapeutic subgroups in which there are no medicines licensed for children.…”

Section: Discussionmentioning

confidence: 97%

Availability of pediatric-evaluated formulations in Serbia

Božić

Stupar²,

Stupar

et al. 2017

Indian J Pharmacol

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 97%

Availability of pediatric-evaluated formulations in Serbia

Božić

Stupar²,

Stupar

et al. 2017

Indian J Pharmacol

View full text Add to dashboard Cite

“…Ceci et al (8), pointed out the positive effect of the EMEA (now known as the EMA) Centralised Procedure and underlined, in particular, that "under the EMEA centralised procedure, several ASs have been licensed for children. Consequently, serious and life-threatening diseases such as AIDS and diabetes are now treatable" and that "the percentage of paediatric medicines approved in a few years by the EMEA was significantly higher than the percentage of paediatric medicines approved under the National or Mutual Recognition European procedures, (33 vs. to 13.2%)."…”

Section: Introductionmentioning

confidence: 99%

Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?

et al. 2021

View full text Add to dashboard Cite

Objectives: In this paper, we investigated the effects of the European Paediatric Regulation (EC) N° 1901/2006 with respect to satisfying the paediatric therapeutic needs, assessed in terms of the increased number of paediatric medicinal products, new therapeutic indications in specific high-need conditions (neonates, oncology, rare disease, etc.) and increased number of paediatric clinical studies supporting the marketing authorisation.Methods: We analysed the paediatric medicinal products approved by the European Medicines Agency in the period January 2007-December 2019, by collecting the following data: year of approval, active substance, legal basis for the marketing authorisation, type of medicinal product (i.e., chemical, biological, or ATMP), orphan drug status, paediatric indication, Anatomical Therapeutic Chemical code (first-level), number and type of paediatric studies. Data were compared with similar data collected in the period 1996–2006.Results: In the period January 1996–December 2019, in a total of 1,190 medicinal products and 843 active substances, 34 and 38%, respectively, were paediatric. In the two periods, before and after the Paediatric Regulation implementation, the paediatric/total medicinal products ratio was constant while the paediatric/total active substances ratio decreased. Moreover, excluding generics and biosimilars, a total of 106 and 175 paediatric medicines were granted a new paediatric indication, dosage or age group in the two periods; out of 175, 128 paediatric medicines had an approved Paediatric Investigational Plan. The remaining 47 were approved without an approved Paediatric Investigational Plan, following the provisions of Directive 2001/83/EC and repurposing an off-patent drug. The analysis of the clinical studies revealed that drugs with a Paediatric Investigational Plan were supported by 3.5 studies/drug while drugs without a Paediatric Investigational Plan were supported by only 1.6 studies/drug.Discussion: This report confirms that the expectations of the European Paediatric Regulation (EC) N° 1901/2006 have been mainly satisfied. However, the reasons for the limited development of paediatric medicines in Europe, should be further discussed, taking advantage of recent initiatives in the regulatory field, such as the Action Plan on Paediatrics, and the open consultation on EU Pharmaceutical Strategy.

show abstract

“…In Europe, fewer than 30 % of marketed drugs include results from paediatric clinical trials and other information on paediatric use in their documentation (Summary of Product Characteristics, SPC or Product Leaflet, equivalent to US label) [ 3 ]. The lack of paediatric medicines is particularly concerning for neonates and in serious and life threatening diseases [ 4 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Successful private–public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

et al. 2014

View full text Add to dashboard Cite

The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres.Conclusion: Notwithstanding the EU contribution for each study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private–public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of off-patent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.

show abstract

Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products

Cited by 34 publications

References 14 publications

Availability of pediatric-evaluated formulations in Serbia

Availability of pediatric-evaluated formulations in Serbia

Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?

Successful private–public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

Contact Info

Product

Resources

About