In late 2018, the EMA published further guidance (Product – or Population‑Specific Consideration IV: Paediatric Population) for review of paediatric safety data in regulatory documents.
The revised guidance, which is not stand-alone and operates within the context of existing GVP Modules I to XVI, was necessitated by a number of important changes since implementation of the 2007 Paediatric Regulation, including increased numbers of:
- Paediatric indications for innovative medicines.
- New paediatric indications for medications with existing licenses in adults.
- New paediatric age‑specific formulations.
Understandably, there is a need for additional considerations when reviewing safety data for paediatrics. Factors including physiological changes during growth and development, immaturity of organs in paediatrics and differences in body mass and composition, may all increase the susceptibility of paediatrics to adverse reactions.
The revised guidance has specific recommendations for analysis of paediatric safety data, in the first instance with regard to the clinical presentation of the adverse reactions, which are likely to differ between adults and paediatrics. The guidance also recommends age‑based cohort review of safety data pertaining to medication errors and off-label use, given the increased likelihood of these issues for paediatrics.
Has this guidance changed the way you review data in your PBRERs?
Have you updated your templates and provided additional guidance for your PV medical writing team?