SIOPE answered to the EMA consultation on the inventory of therapeutic needs in paediatric oncology


EMALast 29th November 2014 SIOPE answered to the European Medicines Agency (EMA) consultation on the draft inventory of paediatric therapeutic needs (paediatric oncology).

The Paediatric Committee at the European Medicines Agency (EMA PDCO) is working to establish an inventory to identify the needs in the different therapeutic areas where there should be research and development of medicinal products for children. The inventory is based on the results of a survey of all paediatric uses of medicines in Europe and on the existing list of paediatric needs established by the former Paediatric Working Party; it will be published progressively by therapeutic area.

SIOPE collected opinions and comments on the inventory from both European Clinical trial groups in paediatric haematology oncology and national paediatric haematology oncology societies, as it is willing to improve interactions with the PDCO and contribute to fine-tune the application of the Paediatric Medicine Regulation to address the real needs of children and adolescents with cancer.

In particular, prioritisation on needs is the key issue to tackle in paediatric oncology drug development, and SIOPE wants to contribute to this challenge. Regarding off-patent oncology drugs which are often used off-label in standard chemotherapy regimens (validated through prospective academic clinical trials over the last 50 years), SIOPE wants to highlight that an important issue is drug shortages in Europe as well as elsewhere in the world that jeopardize access to medicines that cure children and adolescents with cancer.

More information
  • The document open for consultation is available by clicking here.
  • Please contact the SIOPE Office