On February the 2nd 2021, the Frontiers in Medicine journal (Impact factor 3.9) published the article named ‘Paediatric Medicines in Europe: The Paediatric Regulation—Is it Time for Reform?’
The article, written by regulatory experts from the TEDDY Network, is aimed at verifying if the European Paediatric Regulation (EC) N° 1901/2006 satisfies the paediatric therapeutic needs in terms of number of paediatric medicinal products, new therapeutic indications and number of paediatric clinical studies supporting the marketing authorisation.
The results of the investigation showed that the expectations from the Paediatric Regulation have been only partially met. While new innovative medicines have been authorised for the use of paediatric patients, including three advanced therapy medicinal products and 57 medicines for rare diseases, the total number of medicines for children remain lower than medicines for adults (34%) with very few medicinal products for neonates and younger children and no increase for neurologic and oncology drugs.
The Authors conclude that the reasons for the still limited development of paediatric medicines in Europe should be further discussed and modifications to the legislative framework may be suggested taking advantage of recent initiatives in the regulatory field, such as the proposal for modification of both the European Paediatric and Orphan Drug Regulations., and the open consultation on EU Pharmaceutical Strategy.
The complete article is available here.