Pediatric regulation.pptx

PAEDIATRIC REGULATION
PAEDIATRIC REGULATION EC 1901/2006
November the 14th
WINTERGERST Delphine

Summary
I. Introduction
II. The European Paediatric Regulation
1. Paediatric Committee
2. Paediatric Investigation Plan
3. Marketing authorisation
4. Rewards, incentives and penalties
III. Conclusion

Introduction
Paediatric population : “part of the population aged between birth and 18 years”
Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006. Title 1, Chapter 1, Article 2.
20% of the European population are children ⇒100 millions of people
Many of the
medicinal products
currently used to
treat the paediatric
population have
not been studied
or authorised for
such use
Increased risks of
adverse reactions
including death,
ineffective
treatment through
under-dosage, non-
availability to the
paediatric
population
Creation of
Regulation (EC) in
order to develop the
medicinal product
for paediatric use
Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.
European Commission. Progress report on the paediatric regulation EC n°1901/2006. 2013.

The European Paediatric Regulation
Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006
Regulation
(EC) no
1901/2006
facilitate the
development and
accessibility of medicinal
products for use in the
paediatric population
ensure that medicinal
products used to treat the
paediatric population are
subject to ethical
research of high quality
improve the information
available on the use of
medicinal products in the
various paediatric
populations
achieved objectives without
subjecting the paediatric
population to unnecessary
clinical trials and without
delaying the authorisation of
medicinal products for other
age populations
Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.

Structure of regulation (EC) no 1901/2006
Title I: Introductory provisions
Title II: Marketing authorisation requirements
Title III: Marketing authorisation procedures
Title IV: Post-authorisation requirements
Title V: Rewards and incentives
Title VI: Communication and coordination
Title VII: General and final provisions
Source: Regulation (EC) no 1901/2006 of the European parliament and of the council of 12 December 2006.