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More medicines for children: impact of the EU paediatric regulation
Sofia Nordenmalm1, Paolo Tomasi2, Chrissi Pallidis2
1Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Insights
The Paediatric Regulation has significantly improved paediatric drug development in the EU, leading to more medicines for children and better clinical information. This regulation has positively impacted the availability and information surrounding paediatric medicines.
Area of Science:
- Pharmacovigilance and drug development
- Regulatory science
- Paediatric medicine
Background:
- The Paediatric Regulation, enforced on January 26, 2007, aimed to improve the availability of medicines for children.
- Centralised marketing authorisations in the European Union (EU) are the focus of this study.
- Assessing the impact on paediatric drug development and information availability is crucial.
Purpose of the Study:
- To evaluate the effectiveness of the Paediatric Regulation in increasing the number of medicines available for paediatric use in the EU.
- To determine if the Paediatric Regulation has enhanced the availability of paediatric-specific information in the product details of centrally authorised medicines.
- To analyze changes in new medicines, indications, and pharmaceutical forms/strengths for children post-regulation.
Main Methods:
- Retrospective analysis of centrally authorised medicinal products in the EU.
- Inclusion criteria: initial marketing authorisation, type II variation, or line extension approvals.
- Exclusion criteria: products not subject to Paediatric Regulation obligations. Analysis periods: 2004-2006 and 2012-2014.
Main Results:
- Centrally authorised paediatric medicines increased from 20 new medicines and 10 new indications (2004-2006) to 26 new medicines and 37 new indications (2012-2014).
- The number of new pharmaceutical forms or strengths for paediatric use saw a slight decrease from eight (2004-2006) to seven (2012-2014).
- A substantial increase in paediatric-relevant information within the summary of product characteristics was observed in 2012-2014 compared to 2004-2006.
Conclusions:
- The Paediatric Regulation has positively influenced paediatric drug development.
- There is increased availability of medicines for children in the EU following the regulation's implementation.
- Clinicians now have substantially more information regarding the paediatric use of medicines, enhancing clinical practice.
Introduction:
This paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.
Objectives:
To investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.
Materials And Methods:
We retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004-2006 and 2012-2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.
Results:
In 2004-2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012-2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004-2006 and seven in 2012-2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012-2014 compared with 2004-2006.
Conclusions:
The entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information.
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