Module 18 2021

07/02/2021

STRUCTURE of the Application: 5 Discrete Modules…

 Very Important Principle…

 The NATIONAL / REGIONAL requirements for data supporting new drug product applications are unchanged.

 JUST the FORMAT and LAYOUT of the data have been standardised.

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Information in the CTD

 Consider the Reviewer ● Who is the expert on the product?…YOU ● Reviewer/Assessor is not necessarily an expert in YOUR product

● Documents will need to clearly explain the key information and the rationale ● Lead the reviewer through the data so they can follow the story of development and quality ● Good critique-style Module 2 summaries and overviews provide the reviewer with confidence of the underlying detail/data; – Vague or unexplained information - the more the reviewer will need to look at the detail in Modules 3, 4 and 5

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