Regulatory Intervention in Paediatric Medicines - Pharmaceutical Technology

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Regulatory Intervention in Paediatric Medicines
Regulators in both the EU and the US have attempted to stimulate paediatric-drug development with incentives offering extended periods of patent protection, but are these actions having the desired effects?

Pharmaceutical Technology Europe


The introduction of the EU's Paediatric Regulation has led to an increase in clinical trials involving paediatric subjects, but it is unclear whether the effects are what regulators initially desired. In particular, there is concern that the pharmaceutical industry is viewing the incentives as ways to expand sales for products that are already serving adult markets, rather than determining what paediatric medical needs are and prioritising these areas for drug development. From a practical perspective, Enpr–EMA promises much in terms of improving understanding of the field of paediatric drug development and ensuring that Europe has administrative processes conducive to approving such research. The EC is due to report to the European Parliament in 2013 on the impact of the Paediatric Regulation. This time may also be an effective point at which to assess progress with Enpr–EMA.


1. M. Watzl, "The New Paediatric Regulation in the EU – Development, Implications and Comparison with US Experiences in Paediatric Drug Development" (German Society for Regulatory Affairs website, 2007),, accessed 1 Aug. 2012.

2. MHRA, "Medicines for children. Medicines and Healthcare products Regulatory Agency" (MHRA website, 2012),, accessed 1 Aug.

3. EMA, "Report to the European Commission: EMA/480331/2012" (EC website, 2012),, accessed 1 Aug. 2012. 2012.

4. P. Tomasi "The Paediatric Regulation as an instrument for European paediatric research. ENPREMA" (EMA website, 2011),, accessed 1 Aug. 2012.

5. T.M. Olski et al. Eur. J. Clin. Pharmacol. 67 (3), 245-52 (2011).

6. I. Boots et al., Eur. J. Pediatr. 166 (8), 849–855 (2007).

7. EMA, "European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)" (EMA website, 2012)., accessed 1st Aug. 2012.


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