Module 18 2021

07/02/2021

Registration Procedures

Legal Basis:  Depends on… ● The type of data you are submitting ● Whether your drug substance is – New – Well established  Is this… ● A totally new chemical entity? ● A biologic? ● A new formulation? ● A generic?

The Organisation for Professionals in Regulatory Affairs

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Article 8(3) applications

EITHER ● A FULL SET OF SUPPORTING DATA … a whole CTD – Quality, Safety, Efficacy

OR ● A MIXED APPLICATION – Some of the information is replaced with published information

The Organisation for Professionals in Regulatory Affairs

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