CRED Understanding Clinical Development 2024

08/10/2024

Deferrals

• Deferral for initiation and/or completion of an activity can be requested

• A deferred activity is one which takes place after the initial (usually adult) MAA submission date

• The agreement on what will be done and when it will be done cannot be deferred

• Deferrals must be justified on scientific grounds (not commercial priorities)

• Evidence of positive benefit-risk in adults is needed before exposing children

• An age-appropriate formulation and juvenile toxicity data may be needed before studying young children

• It may take longer to study children than adults (e.g. recruitment issues)

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Deferrals

• Deferred measures must still have defined dates for initiation and completion

For clinical trials:

•

• Initiation = date of first patient, first visit

• Completion = date of last patient, last visit

• Anything not deferred must be completed before an MAA can be validated

• The paediatric legislation is not intended to delay the availability of new drugs to adults…

• …but you risk PDCO refusing to grant deferrals if you are late with PIP submission

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