Module232025

The EuPFI STEP database

▪ The STEP (safety and toxicity of excipients for paediatrics) database is a collaborative platform developed by the European Paediatric Formulation Initiative (EuPFI). ▪ It provides a centralized database data related to excipients used in pediatric formulations , supporting informed decisions and ensuring the safety and efficacy of medicines for children. ▪ Collaboration: Facilitates data-sharing between researchers, pharmaceutical industries, and regulatory bodies.

▪ Support: Aids pediatric formulation decision-making with accessible information.

▪ Impact: Enhances the development of safe and age-appropriate pediatric medicines.

▪ The key workstreams of EuPFI guidance focus on

o Palatability: Enhancing taste, smell, and texture to ensure medication adherence.

o Safety of Excipients: Evaluating the safety and tolerability of excipients for pediatric use.

o Dosage Flexibility: Designing formulations that allow for precise dosing based on age or weight.

o Administration Routes: Adapting formulations to convenient and feasible methods of delivery for children.

o Product Acceptability: Balancing child-friendly attributes with therapeutic efficacy.

▪ The guidance supports industry and researchers in designing child-centric medicines.

▪ For further details: https://eupfi.co.uk/

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs