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Oral medicines for children in the European paediatric investigation plans
Diana A van Riet-Nales1, Erwin G A W Römkens2, Agnes Saint-Raymond3
1Medicines Evaluation Board in the Netherlands (MEB), Department of Chemical Pharmaceutical Assessment, Utrecht, the Netherlands; Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, the Netherlands.
Insights
The European Medicines Agency (EMA) review of Paediatric Investigation Plans (PIPs) increased oral dosage forms for children. The review enhanced specific strengths and compositions, particularly for younger age groups, improving paediatric medicine development.
Area of Science:
- Pharmaceutical Science
- Regulatory Science
- Paediatric Medicine
Background:
- The 2007 Paediatric Regulation mandates consideration of children in all new medicine development.
- Paediatric Investigation Plans (PIPs) are required for agreement with the European Medicines Agency (EMA) and its Paediatric Committee (PDCO).
Purpose of the Study:
- To evaluate key characteristics of oral paediatric medicines within PIPs.
- To assess changes made to PIPs following EMA/PDCO review.
Main Methods:
- Identified PIPs agreed by December 31, 2011, focusing on oral medicines for children aged 0-11 years.
- Extracted data on therapeutic area, target age range, and pharmaceutical characteristics (dosage form, strength, excipients) from EMA resources.
Main Results:
- 150 PIPs analyzed, covering 16 therapeutic areas and 220 oral dosage forms.
- EMA/PDCO review increased oral dosage forms by 13 and specific strengths/compositions by 44, with a focus on younger children.
- Target age ranges were often widened, and excipient composition/usability were modified.
Conclusions:
- EMA/PDCO review significantly increased the number of oral dosage forms and specific compositions/strengths for paediatric use.
- The review particularly enhanced formulations targeting younger children.
- Pharmaceutical design modifications were less substantial compared to the increase in dosage form requirements.
Introduction:
Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric Investigation Plans (PIPs) are subject to agreement by the European Medicines Agency (EMA) and its Paediatric Committee (PDCO). The aim of this study was to evaluate the key characteristics of oral paediatric medicines in the PIPs and the changes implemented as a result of the EMA/PDCO review.
Methods:
All PIPs agreed by 31 December 2011 were identified through a proprietary EMA-database. PIPs were included if they contained an agreed proposal to develop an oral medicine for children 0 to 11 years. Information on the therapeutic area (EMA classification system); target age range (as defined by industry) and pharmaceutical characteristics (active substance, dosage form(s) as listed in the PIP, strength of each dosage form, excipients in each strength of each dosage form) was extracted from the EMA website or the EMA/PDCO assessment reports.
Results:
A hundred and fifty PIPs were included corresponding to 16 therapeutic areas and 220 oral dosage forms in 431 strengths/compositions. Eighty-two PIPs (37%) included tablets, 44 (20%) liquids and 35 (16%) dosage forms with a specific composition/strength that were stored as a solid but swallowed as a liquid e.g. dispersible tablets. The EMA/PDCO review resulted in an increase of 13 (207 to 220) oral paediatric dosage forms and 44 (387 to 431) dosage forms with a specific composition/strength. For many PIPs, the target age range was widened and the excipient composition and usability aspects modified.
Conclusion:
The EMA/PDCO review realized an increase in the number of requirements for the development of oral dosage forms and a larger increase in the number of dosage forms with a specific composition/strength, both targeting younger children. Changes to their pharmaceutical design were less profound.
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