Guidance for Industry M4: Organization of the Common Technical Document

Name of Guidance: Guidance for Industry. M4: Organization of the Common Technical Document (CTD)

Status of Guidance: Final

Date of Guidance: August 2001

Name of Organizations Releasing the Guidance:

• International Conference on Harmonisation (ICH)
• United States Department of Health and Human Services, Food and Drug Administration (FDA)
• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)

Target Audience: This guidance is targeted to applicants preparing the CTD for the registration of pharmaceutical products with the corresponding regulatory agency.

Laws and Regulations Referenced: None

Guidance Referenced:

• General Considerations for Submitting Marketing Applications According to the ICH/CTD Format – This guidance describes the organization of new drug applications, abbreviated new drug applications and biological license applications for submission to the FDA.
• Guidance that describe formatting for specific subsections of the CTD:
• M4Q: The CTD – Quality
• M4S: The CTD – Safety
• M4E: The CTD – Efficacy
• Uniform Requirements for Manuscripts Submitted to Biomedical Journals – Guidance sited to address references.

Definitions:

• Common Technical Document (CTD) – Also referred to as electronic CTD (eCTD). It is the standard format for submitting regulatory documents to Drug Regulatory Agencies in Europe, Japan, and the United States.
• GAIYO – Part of Japanese dossier. Summarizes all technical information of the drug under review.

Background:

The CTD was created through the International Conference on Harmonisation in an effort to simplify regulatory submission efforts among three main regulatory regions, Japan, Europe, and the United States. The same documents can be submitted to Japan, Europe and the United States for regulatory evaluation. This guidance addresses general formatting and presentation of data collected.

Summary:

The CTD is organized by sections or ‘Modules’. This guidance gives specific information on the order and numbering for all documents to be included in each Module:

· Module 1 is region specific and contains administrative information specific to each regulatory agency receiving the documents (GAIYO for Japan) including an application form, and the proposed label for the region.

· Module 2 gives a general description of the drug being evaluated and it contains summaries and overviews of the studies included in the regulatory submission.

· Module 3 contains all the quality information relevant to the regulatory submission.

· Module 4 contains nonclinical study reports.

· Module 5 contains clinical study reports.

Rationale:

The CTD was created to reduce or eliminate the requirement for industries to adapt their documents for each of the ICH regions,[1] and to expedite the review processes.

Resulting Recommendations:

• Harmonization of technical requirements across 3 regulatory agencies.
• Reduction of animal and human testing without compromising the safety or efficacy of the new test product.

Impact:

• Reduction of testing and reporting in the development of new medicines[2] - Creation of a common approach to drug approval among the 3 main regulatory agencies (the CTD) has enabled the industry to reduce the number of trials performed to accommodate each regulatory agency’s requirements, and by this the reporting of findings has been reduced.
• Cost savings for industry² – The harmonization of drug regulatory documents has made an impact in cost reduction. Fewer personnel hours are needed, the utility bills are lower, and the expenses in computer software and hardware have also been decreased.
• Improvement in communication between regulatory agencies and industry² –With the development of the CTD, regulatory agencies have been able to create review templates and expedite review practices.

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[1] International Conference on Harmonisation website. M4: The common Technical Document. http://www.ich.org/products/ctd.html. Accessed 09 June 2011.

[2] International Conference on Harmonisation website. The value and benefits of ICH to drug regulatory authorities. http://www.ich.org/fileadmin/Public_Web_Site/News_room/C_Publications/ICH_20_anniversary_Value_Benefits_of_ICH_for_Regulators.pdf. Accessed 10 June 2011.