PP-38 Getting paediatric medicines on-label – scoping the needs for paediatric formulation of old medicines

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Abstract

The Rosalind and Morris Goodman Family Paediatric For-mulations Centre of the CHU Sainte-Justine is a new non-profit organisation dedicated to supporting the development of safe and efficacious medicines that have a child-friendly formulation. One way of providing these paediatric medicines is to partner with industry to promote commercialising of a suitable paediatric formulation for commonly used medicines currently only avail-able in adult formulations. Working with all stakeholders including, pharmacists, paediatricians, Health Canada and the pharmaceutical industry, the Goodman Centre has identified commonly used off-label medicines that are currently compounded in pharmacies to produce pedi-atric formulations. In many cases, paediatric formulations and indications are available in other jurisdictions yet they have not been submitted by industry to Health Canada for regulatory approval. Using this novel approach, the Centre is to partnering with pharmaceutical companies to use existing data that has been submitted in other jurisdictions for Canadian approval. We will provide an overview of the Goodman Centre and outline the novel approach developed to improve access to paediatric for-mulations that we have undertaken.

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