Recommendations for drug development for children

One of TEDDY objectives is to “to identify unmet therapeutic needs for the development and use of medicinal products in male/female children” and it is compliant with the new provisions established by the Paediatric Regulation. Thus TEDDY set up 12 Therapeutic Experts Groups (TEGs) to identify the needs in some therapeutic areas of paediatric interest. Starting from the Assessment Documents released by EMEA-PEG and later on by EMEA-PDCO, a total of 14 therapeutic areas were analysed. TEDDY experts have identified 442 products that need to be specifically developed for children by either extending the current authorised indication or developing new indications. Moreover, the study shows that a total of 1480 studies (i.e. PK, dosage, efficacy, safety or long term safety) should be conducted in order to develop more drugs for children. In the light of these results, it is reasonable to question if all these studies are absolutely necessary and consequently if there are enough children to be enrolled in the trials for the same therapeutic area. It is imperative to adopt a procedure of selecting which drugs need to be developed for each therapeutic area in order to avoid repetitive and unnecessary trials in children.