Spring Intro 2023

03/03/2023

There is a number of guidelines to help you write these documents: ICH M4 - Common Technical Document for the Registration of Pharmaceuticals for Human Use – Organisation CTD ICH M5 - Units and Measurements, Controlled Vocabulary And A Guideline on Summary of Product Characteristics (SmPC) - September 2009

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Note that the ICH M4 guideline only tells you where in the dossier certain data go.

It does not tell you what studies need to be conducted!

ICH M3 (R2) - Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals should be consulted for that information. But this guideline only tells you when, but not how.

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