The EMA's Paediatric Committee: Progress and Challenges-Faraz Kermani talks to the European Medicines Agency's Paolo Tomasi and Agnes Saint Raymond about the PDCO's progress and the challenges it still faces.

摘要

By far the most important task of the European Medicines Agency's Paediatric Committee is to assess the content of and adopt opinions on the paediatric investigation plans (PIPs) that drug companies are required to submit for the products they are developing. In the approximately three years since the committee was set up - under the Paediatric Regulation ((EC) No 1901/2006) - it has dealt with over 1,000 applications. Most of these relate to new PIPs but many relate to modifications or second or third PIPs for the same substance. "So far, the PDCO has not missed a single deadline, which is something I think that we should be proud of," Paolo Tomasi, EMA head of section, paediatric medicines, told RAJ Pharma.