Affiliations: PDCO, EMA, London, UK. E-mail:
Abstract: The introduction of innovation into the drug development process is
expected to bring to patients, including children, in the upcoming years a
faster treatment, increased safety in term of side effects and tolerability,
decreased interactions with other drugs, increased compliance, new treatments
for untreated disorders, and increased quality of life and life duration. The implementation of the European Regulation EC/1901/2006 "Better Medicines for
the Children of Europe" and EC/1902/06 foresaw the creation at the EMA of a
new Paediatric Committee and assigned it a number of tasks. The legal provision
also forced Industry to develop their new drugs for children as soon as
reasonably sound, as appropriate. An early paediatric investigation plan (PIP)
is to be submitted to the PDCO as soon as the concept of the candidate
medicinal product is sufficiently established in adults, at the end of phase I.
The PIP has to be agreed by the PDCO, some room being left over for
discussions, modifications and amendments whilst the candidate medicinal
product will evolve along its life cycle.