Module 18 2021

07/02/2021

WHAT ABOUT THE USA

NDA • This is a “full” application where the applicant provides clinical and/or literature support.

ANDA • This is an “Abbreviated” application, similar to a “generic” application in the EU

OTC (monograph) •

This is a different system whereby there are requirements listed in the CFR, where, provided the product meets these requirements, it can be marketed, without a prior review/approval by FDA

BLA • This is the acronym for an application for a biological product

The Organisation for Professionals in Regulatory Affairs

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WHAT ABOUT THE USA

• CTD format is applicable

• Some differences in the content but the majority will be similar

• Module 1 – Administrative information • This Module is region specific and will be different to an EU Module 1

• Different Approach to review • Bottom up vs top down

The Organisation for Professionals in Regulatory Affairs

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