ICH M4(R4) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Title:
ICH M4(R4) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Short Title:
M4(R4)

https://www.gmp-compliance.org/files/guidemgr/M4_R4__Granularity_Document.pdf

Origin/Publisher:

Document Type:
ICH Guideline
Content:
This guideline presents the common format for the preparation of a well-structured Common Technical Document for applications that will be submitted to regulatory authorities.

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