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ICH M4 Guideline Common Technical Document for the Registration

What is the common technical document for the registration of pharmaceuticals?
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada and Switzerland.
What is M4 in ICH guidelines?
M4 : The Common Technical Document
For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
The CTD is organised into five modules.
Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions.
What are the 3 main types of ICH guidance documents?
It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Module 4: Non-clinical Study reports/ Safety
The data in this module pertains to non-clinical or pre-clinical studies conducted for the drug product.
This Module typically includes studies related to Pharmacology, Pharmacokinetics, Pharmacodynamics, Toxicology as relevant to the drug product._{24 août 2022}

1 fév. 2004 · Guidance on the organisation of the information to be presented in registration applications for new pharmaceuticals (including Autres questions

ICH M4 Guideline Common Technical Document for the Registration

What is the common technical document for the registration of pharmaceuticals?

What is M4 in ICH guidelines?

What are the 3 main types of ICH guidance documents?