ReviewArchives of disease in childhood2007
The EU's new paediatric medicines legislation: serving children's needs?
Review in Archives of disease in childhood, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis.Anesthesiology · 2015Pooled it
- Neonatology: First Exposure to Antibiotics from the Ethical Perspective of Parents, Physicians, and Regulators.Antibiotics (Basel, Switzerland) · 2025Article
- Clinical trials of stem cell-based therapies for pediatric diseases: a comprehensive analysis of trials registered on ClinicalTrials.gov and the ICTRP portal site.Stem cell research & therapy · 2022Article
- Paediatric outpatient prescriptions in France between 2010 and 2019: A nationwide population-based study: Paediatric outpatient prescriptions in France, 2010 to 2019.The Lancet regional health. Europe · 2021Article
- The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.Therapeutic innovation & regulatory science · 2020Article
- Parents' attitudes towards and perceptions of involving minors in medical research from the Japanese perspective.BMC medical ethics · 2018Article
- Clinical trials in children.British journal of clinical pharmacology · 2015Review
- How to optimize the evaluation and use of antibiotics in neonates.Pediatric clinics of North America · 2012Review
- 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
- Disease registries and outcomes research in children: focus on lysosomal storage disorders.Paediatric drugs · 2011Review
- Access to children's medicines in the United Kingdom, Australia and New Zealand in 1998, 2002 and 2007.Pharmacy world & science : PWS · 2010Article
- The unintended consequences of clinical trials regulations.PLoS medicine · 2009Article
- Delivering better medicines to children: need for better integration between the science, the policy, and the practice.Paediatric drugs · 2009Article
- The new European regulation on pediatric medicines: regulatory perspective.Paediatric drugs · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In new legislation for paediatric medicines which came into effect on 26 January 2007, the European Union (EU) has attempted to address several unresolved issues relating to children's needs for medicines in Europe. This article reviews the legislation's main proposals and makes some comparisons with equivalent legislation in the USA. We argue that the legislation suffers from several gaps and uncertainties in relation to the specific proposals and their intended aims. As the establishment of new legislation in this area offered the EU an opportunity to set some clear guidelines and objectives, and had the potential to go beyond the equivalent American rules, we thus see the proposals as something of a disappointment.
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Identifiers
What OpenQuestion holds
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.