ArticleItalian journal of pediatrics2010
The European paediatric legislation: benefits and perspectives.
Article in Italian journal of pediatrics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.Pharmaceutics · 2025Review
- Article
- Suitability of paediatric legislation beyond the USA and Europe: a qualitative study on access to paediatric medicines.BMJ public health · 2024Article
- Public health relevance of medicines developed under paediatric legislation in Europe and the USA: a systematic mapping study.BMJ paediatrics open · 2024Article
- Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil.Health research policy and systems · 2024Article
- International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.Clinical pharmacology and therapeutics · 2020Article
- Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study.European journal of pediatrics · 2020Article
- The Unlicensed and Off-label Prescription of Medications in General Paediatric Ward: An Observational Study.Current pediatric reviews · 2019Observational
- Off-label drugs use in pediatric palliative care.Italian journal of pediatrics · 2018Article
- Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.BMC pediatrics · 2018Observational
- Early phase clinical trials of anticancer agents in children and adolescents - an ITCC perspective.Nature reviews. Clinical oncology · 2017Review
- Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.European journal of pediatrics · 2016Review
- Children with multiple sclerosis should not become therapeutic hostages.Therapeutic advances in neurological disorders · 2016Review
- Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia.International journal of clinical pharmacy · 2015Article
- The crisis of capitalism and the marketisation of health care: the implications for public health professionals.Journal of public health research · 2012Article
- Does market exclusivity hinder the development of Follow-on Orphan Medicinal Products in Europe?Orphanet journal of rare diseases · 2011Article
- Pharmacokinetic research in children: an analysis of registered records of clinical trials.BMJ open · 2011Article
- Framework conditions facilitating paediatric clinical research.Italian journal of pediatrics · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe lack of availability of appropriate medicines for children is an extensive and well known problem. Paediatricians and Physicians who take care of the paediatric population are primarily exposed to cope with this negative situation very often as more than half of the children are prescribed off-label or unlicensed medicines. DISCUSSION: Medicinal products used to treat this population should be subjected to ethical research of high quality and be explicitly authorized for use in children as it happens in adults. For that reason, and following the US experience, the European Paediatric Regulation has been amended in January 2007 by the European Commission. The objective of the Paediatric Regulation is to improve the development of high quality and ethically researched medicines for children aged 0 to 17 years, to facilitate the availability of information on the use of medicines for children, without subjecting children to unnecessary trials, or delaying the authorization of medicines for use in adults. SUMMARY: The Paediatric Regulation is dramatically changing the regulatory environment for paediatric medicines in Europe and is fuelling an increased number of clinical trials in the paediatric population. Nevertheless, there are some risks and pitfalls that need to be anticipated and controlled in order to ensure that children will ultimately benefit from this European initiative.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.