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The Paediatric Committee (PDCO)

The Paediatric Committee (PDCO) is the scientific committee of the European Medicines Agency (EMA) responsible for the scientific assessment and adoption of paediatric investigation plans (PIPs) in its main role.

A PIP specifies the paediatric studies that pharmaceutical companies must conduct if they want to develop a new medicinal product and bring it to market in a national or central marketing authorisation procedure - even if this is (initially) only intended for use in adults. The main task of the PDCO also includes the assessment of applications by pharmaceutical companies for deferrals of the initiation or completion of some or all of the PIP measures, as well as the assessment of applications for waivers of the obligation to submit a PIP, which may relate to parts (partial waiver) or the entire paediatric population (full waiver). However, the Paediatric Committee is not responsible for assessing applications for marketing authorisation for medicinal products for children. This falls within the remit of the Committee for Medicinal Products for Human Use (CHMP) and the national authorities.

The Paediatric Committee was established in 2007 under the Paediatric Regulation (Regulation (EC) No 1901/2006) to improve the health of children in the European Union by promoting the development and availability of medicines for children aged 0-17 years.

The Paediatric Committee consists of scientific experts from all Member States of the EEA, including patient representatives and healthcare professionals. For further information on the PDCO and an overview about all adopted PIPs, please refer to the EMA website.

The German PDCO delegate is Dr. Sabine Scherer. Her representative is Dr. Yuansheng Sun from Paul-Ehrlich-Institute (PEI).

All agendas, minutes and meeting reports of the PDCO meetings published by the EMA can be found here.