The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.
"A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic submissions," the guidance says.
It provides recommendations on the organization of the CTD and the electronic common technical document (eCTD) for Modules 2 through 5, with direction on the location and hierarchy of headings within modules, document pagination and segregation, section numbering and the formatting of the table of contents.
The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions, and includes appendices for eCTD v4 submissions to facilitate the implementation of the next major version of the eCTD.
The M4Q CTD and M8 eCTD Implementation Working Groups of ICH developed the guidance and it has been subject to consultation by the regulatory parties, in accordance with the ICH process.
In June 2016, the guidance reached Step 4 of the ICH process, meaning the final draft is recommended for adoption to FDA and regulators from the EU, Japan, Canada and Switzerland.
This guidance also replaces two other FDA guidance documents: a previous version of M4 from 2001 and the granularity document annex from 2005.
"This guidance is not intended to indicate what studies are required. It merely indicates an appropriate format for the data that have been acquired. Applicants should not modify the overall organization of the CTD as outlined in the guidance. However, in the Nonclinical and Clinical Summaries, applicants can modify individual formats if needed to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results," it says.
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry
Editor’s note: RAPS will host intermediate eCTD submissions workshops
19–20 October in San Diego, CA, and 6–7 November in Frankfurt, Germany.