Spring Intro 2023

30/03/2023

Conditional Authorisation

Allows authorisation with less comprehensive data than normally required • where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required Eligibility • Medicines for seriously debilitating or life-threatening diseases • Emergency situations, public threats duly recognised either by the WHO or by the EC • Orphan diseases

Requirements •

Benefit/ Risk balance is positive • It is likely that the applicant will be able to provide the comprehensive clinical data • Unmet medical needs will be fulfilled • Benefit to public health of the immediate availability outweighs the risk due to need for further data

The Organisation for Professionals in Regulatory Affairs

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Conditional Authorisation

Conditions •

Authorisation valid for one year, on a renewable basis • Specific obligations include completion of ongoing or new studies, and in some cases additional activities • Once comprehensive data available, MA may be converted into a standard MA

Application process •

Early dialogue – scientific advice/protocol assistance • Discuss proposal at pre-submission meeting with EMA – 6/7 months in advance of MAA submission • Formal request submitted at time of MAA submission • Application encouraged to also consider accelerated assessment

The Organisation for Professionals in Regulatory Affairs

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