Michael O'Donnell Blog Post #2

Name of Guidance: International Conference on Harmonization (ICH) - Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD

Status: Final within ICH, but at time of update was still pending inclusion in future revised FDA M4 guidance

Release Date: October 2005

Link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129555.htm

Target Audience: Regulatory operations departments in pharmaceutical companies, or individual preparers of Common Technical Document (CTD) -based submissions to the US Food and Drug Administration (FDA)

Laws and Regulations Referenced: None

Guidances referenced: ICH M4 Guidance

Summary: This guidance is an annex to a previous International Conference on Harmonisation (ICH) guidance on CTD assembly and organization, and is included among FDA guidances due to the FDA being an ICH participant. The fundamental organization of the CTD used in regulatory submissions is explained, with a strong emphasis on the concept of document granularity. The guidance answers definitively these two basic questions:

1. What is officially considered a document in a paper submission?

2. What is a document in an electronic or digital submission?

Rationale: The annex became necessary to provide answers to numerous questions raised by the target audience of the original M4 guidance. By further explaining granularity, and how this concept contributes to pagination and table of contents structure, documents from Module 2 through Module 5 have a road-map for the complete understanding of internationally compliant document assembly.

Resulting Recommendations: The ICH recommends that this guidance be utilized by its participating regulatory agencies: the FDA, the European Medicines Agency (EMEA), and Japan's Ministry of Health, Labour, and Welfare (MHLW).

Impact: This guidance explicates what constitutes a CTD document format, as well as an electronic Common Technical Document (eCTD) format. Explained in detail are the management of multiple documents within the same module, resulting pagination, format, and table of contents issues encountered during CTD and eCTD submissions. Embracing document granularity in a CTD format as the accepted international standard allows for greater global sharing of pharmaceutical information. Perhaps of equal importance, when this standard is adhered to properly, is that submission review turnaround time is reduced significantly.