Question: If a Sponsor is intending to create both an eCTD, and a future paper - based CTD for their Rest of the World ( ROW

If a Sponsor is intending to create both an eCTD, and a future paper

-

based CTD for their Rest of the World

(

ROW

)

markets.

Assess the scenario: To meet the requirements of the eCTD Granularity assessment which ICH guideline completely describe the requirements of unique headers and footers to include specific subject matter?

.)

ICH M

4

Granularity Document

.)

ICH MB

.)

ICH M

2

Granularity Document

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