EMA Pediatric Committee reports on progress
Since the Pediatric Regulation came into force in the European Union in 2007, pharmaceutical companies have had a legal obligation to develop all new medicines for children as well as for adults through a pediatric investigation plan (PIP), unless they obtain an exemption (waiver).
A similar obligation also applies, in some cases, to medicinal products that are already authorized in the EU. The European Medicines Agency’s Pediatric Committee (PDCO) has released the fist five-year report to the European Commission on the experience acquired on the Pediatric Regulation and its achievements this far.
What has been achieved in five years?
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