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Quality of Harmonized Drug Substance Dossier for a Marketing Authorization

BayBiotech.NET

Through the ICH process (ICH M4Q), considerable harmonization has been achieved among the three regions (Japan, EU and US) in the technical requirements for the registration of pharmaceuticals for human use. To avoid the need to generate and compile different registration dossiers, the ICH: M4 guideline describes a format for the Common Technical Document that will be acceptable in all three regions.

In a nutshell, CTD is an internationally agreed upon format for the preparation of a presentation for applications to be submitted to the regulatory authorities. However, the CTD does not address the content of submissions. There are many regional requirements, as well as applicants’ preferences, that could affect the contents of dossiers submitted in each region.

According to the ICH guidelines, a document is defined for a paper submission as a set of pages, numbered sequentially and divided from other documents by a tab and a document can be equated to a file for an electronic submission. In an electronic submission, a new file starts at the same point at which in a paper submission, a tab divides the documents.
In deciding whether one or more documents or files are appropriate, it should be considered that once a particular approach has been adopted, the same approach should be used throughout the life of the dossier since it is the intention that replacement documents/files be provided when information is changed.

It is recommended that all the text and tables should be prepared using margins that allow the document to be printed on A4 paper (EU and Japan) and 8.5x11” paper (USA). Times New Roman, 12-point font is recommended for narrative text.

For more details follow the link: ICH M4Q Guideline Common Technical Document for the Registration of Pharmaceuticals for Human use, Quality

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