SIOPE Paper on the Revised EMA Class Waiver List

An important SIOPE paper on paediatric oncology drug development has just been published on the Lancet Oncology journal.

The 2007 European Paediatric Medicine Regulation requires a paediatric investigation plan (PIP) for any drug being developed for adults before marketing authorisation is given, unless a waiver is granted by the European Medicine Agency (EMA) Paediatric Committee (PDCO). Waivers provide exemption from the obligation to submit a PIP or specific waiver request, and they can be given because the medicine is likely to be ineffective, unsafe, not have a significant therapeutic benefit over existing treatments for children and adolescents, or intended to treat an illness that only occurs in adults. The PDCO has recently revised the current list of class waivers for medicines that are not required to submit a PIP aiming to, hopefully, encourage companies to develop more new medicines for use in children.

Co-written by several SIOPE partners, the article ‘Will the revised class waiver list make it?’ explains what is the foreseen anticipated impact of the recent PDCO revision of this class waivers’ list.

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