As part of the enactment of the Paediatric Regulation, EMA established a Paediatric Committee that commenced its work in July 2007. It is a panel of experts with no interests in the pharmaceutical industry appointed by the Member States. The members of the committee are required to possess special expertise in disciplines of science significant to paediatric medicine.
Aside from the appointees of the Member States, the Paediatric Committee includes three health professionals and three representatives of patient associations. Alternates have also been appointed for all the committee members. The members of the Paediatric Committee are appointed for a renewable term of three years.
The Paediatric Committee convenes 12 times a year to evaluate investigation plans for paediatric medicines as well as requests for waivers and deferrals. A report on the Committee’s first year of activities has been posted on EMA’s website. Additionally, EMA issues press releases on the committee meetings.
The tasks of the Paediatric Committee include the following:
• to assess the content of any paediatric investigation plan for a medicinal product and formulate an opinion thereon;
• to assess waivers and deferrals and formulate an opinion;
• to assess compliance of the application for a marketing authorisation with the agreed paediatric investigation plan concerned and formulate an opinion thereon;
• to assess any data generated in accordance with an agreed paediatric investigation plan and formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population;
• to support and advise the Agency on establishing the European network with specific expertise in the performance of studies in the paediatric population;
• to provide advice on any question related to medicinal products for use in the paediatric population to EMA’s other committees and working parties and the Commission;
• to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis.