Spring Intro 2023

16/02/2023

Non-clinical Considerations

Non-clinical Studies Are Not Normally Required But Sometimes: • Different salt/ester moiety • Non-conventional excipients* • Qualification of related substances/degradation products*

Main component of M4 for generic applications is normally literature referenced in the non-clinical overview.

*Would be included in M3 (i.e. not M4)

The Organisation for Professionals in Regulatory Affairs

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CMC Related Considerations Key section of M3 that’s “different” for a generic dossier is the pharmaceutical development which focuses on establishing pharmaceutical equivalence to the reference product: • Reference product is the starting point for all generic developments • Tells the story of how equivalence to the reference product was achieved • Ultimate goal is meeting in vitro release profile of the reference product • Comparison against BE test product to support waiver of strengths (normally comparative dissolution across the physiological pH range) • Comparison against reference product to support full biowaiver • Can be very involved (e.g. colloidal parenterals)

The Organisation for Professionals in Regulatory Affairs

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