Article Text

THE NEW PAEDIATRIC REGULATION “BETTER MEDICINES FOR THE CHILDREN OF EUROPE” AND CLINICAL RESEARCH
  1. D Brasseur1,2,3
  1. 1PDCO, Paediatric Committee—EMEA European Medicines Agency
  2. 2Belgian Federal Agency for Medicines and Medicinal Products, Belgium
  3. 3Hôpital des Enfants Reine Fabiola, Université Libre de Bruxelles, Brussels, Belgium

Abstract

The EU Parliament has adopted a new legislation 1901/1902–2006 in order to facilitate the development of paediatric drugs. The three legal pillars are the adoption of incentives for industry, the implementation of mandatory paediatric investigation plans (PIP) and the creation of a Paediatric Committee (PDCO). Industry will benefit from an additional 6 months protection for drug developments having complied with an agreed PIP. If not compliant, the new compound might not be eligible for any adult submission. Orphan drugs will benefit from a 2-year extension of their market exclusivity if following correctly the same and obligatory track. Compounds having no indication to treat children are waived from these obligations. Finally, out-patented medicines can on a voluntary basis apply for a PIP and get 10 years protection of their data. This provision intends to decrease “off-label” use. After 9 months of implementation, more than 170 PIP have been evaluated corresponding to more than 340 indications. As such, all age ranges, from premature neonates to adolescents are being systematically considered when designing PIP. Efficacy and safety data are often collected first, older children envisaged later, before moving to infants or neonates. These programmes will have an important impact on EU paediatric research involving potentially important cohorts of children and their families, implying the collaboration of researchers, industry, public health authorities and regulatory bodies across Europe. The input of all parties in an effective network is needed to make this initiative a success.

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