Regulatory Intervention in Paediatric Medicines - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology Europe,
Click here