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The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric

Stefan Wimmer1, Wolfgang Rascher, Suzanne McCarthy

  • 1Department of Paediatrics and Adolescent Medicine, University Hospital Erlangen, Loschgestraße 15, 91054, Erlangen, Germany.

Paediatric Drugs
|July 25, 2014
PubMed

Insights

The EU Paediatric Regulation has not fully addressed unmet needs for off-patent medicines in children. More research funding is crucial to improve paediatric pharmacotherapy and ensure safe, effective treatments for childhood conditions.

Area of Science:

  • Pharmacology
  • Regulatory Science
  • Paediatric Medicine

Background:

  • The European Medicines Agency (EMA) identified unmet paediatric needs for existing medicines before the EU Paediatric Regulation.
  • Seven years post-implementation, this study assesses progress in addressing these identified needs.

Purpose of the Study:

  • To evaluate the impact of the EU Paediatric Regulation on generating evidence for paediatric medicines.
  • To determine the extent to which previously identified unmet paediatric needs have been addressed through regulatory programs.

Main Methods:

  • Systematic screening of EMA and CORDIS databases.
  • Identification of active substances with unmet paediatric needs, off-patent priority lists, Paediatric Investigation Plans (PIPs), and FP7 projects.

Main Results:

  • 357 active substances with paediatric needs identified; 511 PIPs agreed.
  • Only 14.3% of PIPs addressed previously identified needs, with few for off-patent drugs.
  • Cardiovascular diseases, cancer, and anaesthesiology showed significant unmet needs, but PIPs were scarce for cardiovascular and anaesthesiology drugs.

Conclusions:

  • Most Paediatric Investigation Plans (PIPs) focus on new medicines, leaving many off-patent drugs for common childhood conditions understudied.
  • Increased research funding and efforts are vital to standardize and improve paediatric pharmacotherapy.
Abstract

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