Module232025

07/05/2025

What is a deferral?

• A deferral allows for delay of initiation and/or completion of measure in relation to submission of the MAA • Must be justified on scientific and technical grounds or on grounds related to public health • e.g. Safety data required in adults before initiating studies in paediatric subjects , or paediatric studies will take longer to conduct than adult studies • To note: After MAA, annual reports on status of all deferred measures of the ongoing paediatric development must be submitted

The Organisation for Professionals in Regulatory Affairs

PIP Development

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PIP strategy options

• Full development plan • Development plan with waivers for paediatric sub-sets and/or deferrals • Product Specific Waiver (PSW) = proposed waiver covering all paediatrics for the proposed condition • Class Waiver = EMA pre-defined list of classes of medicines and conditions for which the grounds of a waiver are deemed to apply – confirmation request still needs to be submitted via IRIS • Stepwise PIP (via Pilot)

The Organisation for Professionals in Regulatory Affairs

PIP Development

10