Module232025

07/05/2025

What are measures?

• Measures are a specific activity to be conducted to generate data to support the use of a medicinal product in the paediatric population • This can be a clinical study, non-clinical study or development activity (e.g. paediatric formulation development) • Measures are a key part of the agreed PIP and specified aspects will become legally binding

The Organisation for Professionals in Regulatory Affairs

PIP Development

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What is a waiver?

• A waiver can be granted when development of a medicine in paediatrics is not needed or not appropriate • Possible grounds include: • The medicinal product is likely to be ineffective or unsafe for all or some paeds • The disease or condition only occurs in adult populations • There is no significant benefit over existing treatments in paeds • This applies to either paediatric sub-sets (e.g. age groups, sex) and/or the entire indication

The Organisation for Professionals in Regulatory Affairs

PIP Development

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