Spring Intro 2023

16/02/2023

Committees of EMA (2)

Paediatric Committee (PDCO) ● Assess the content of paediatric investigation plans (PIPs), which determine the studies that companies must carry out in children when developing a medicine. This includes assessing applications for a full or partial waiver and for deferrals. Committee for Orphan Medicinal Products (COMP) ● The COMP is responsible for evaluating applications for orphan designation. This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU. The European Commission decides whether to grant an orphan designation for the medicine based on the COMP's opinion Committee for Advanced Therapies (CAT) ● Committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.

7

Committees involved in “national” procedures

• NCA committees • Heads of Medicines Agencies • Network of the heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use • Co-ordinates with EMA and EC • Co-ordinates MRP/DCP • CMDh : Coordination Group for Mutual Recognition and Decentralised procedures- Human

8