Paediatric Committee (PDCO)

Overview

Role and responsibilities

The main responsibility of the Paediatric Committee (PDCO) is to assess the content of paediatric investigation plans and adopt opinions on them in accordance with Regulation (EC) 1901/2006 as amended. This includes the assessment of applications for a full or partial waiver and assessment of applications for deferrals.

Other tasks of the Paediatric Committee include:

assessing data generated in accordance with agreed paediatric investigation plans and adopting opinions on the quality, safety or efficacy of any medicine for use in the paediatric population (at the request of the Committee for Medicinal Products for Human Use or a competent authority);
advising Member States on the content and format of data to be collected for a survey on all existing uses of medicinal products in the paediatric population;
advising and supporting the EMEA on the creation of a European network of persons and bodies with specific expertise in the performance of studies in the paediatric population;
providing advice on any question relating to paediatric medicines (at the request of the EMEA Executive Director or the European Commission);
establishing and regularly updating an inventory of paediatric medicinal product needs;
advising the EMEA and the European Commission on the communication of arrangements available for conducting research into paediatric medicines.

The PDCO is not responsible for marketing-authorisation applications for medicinal products for paediatric use. This remains fully within the remit of the Committee for Medicinal Products for Human Use (CHMP). However, the CHMP or any other competent authority may request the PDCO to prepare an opinion on the quality, safety and efficacy of a medicinal product for use in the paediatric population if these data have been generated in accordance with an agreed paediatric investigation plan.

Composition

The Paediatric Committee is composed of:

five CHMP members with their alternates, appointed by the CHMP itself;
one member and one alternate appointed by each Member State (except Member States already represented through the members appointed by the CHMP);
three members and alternates representing healthcare professionals;
three members and alternates representing patients' associations.

Members of the PDCO are appointed for a renewable period of three years. The Chair of the PDCO will be elected from its members.

See PDCO members for the list of current members.

Rules of procedure

The 'PDCO rules of procedure' provide full details of the PDCO's responsibilities, composition and the roles of its members.

Paediatric Committee - Rules of procedure (EMEA/3448440/2008)

Roles and responsibilities of members and alternates, rapporteurs, peer reviewers, observers and experts at the PDCO meetings.

PDCO – Roles and responsibilities at PDCO meetings (EMEA/537415/2008)