General principles of CTD
The General Principles of CTD provide a harmonised approach to organising and presenting quality, safety and efficacy information in regulatory applications for pharmaceuticals for human use. Developed through the International Council for Harmonisation (ICH), the Common Technical Document helps applicants organise regulatory information consistently and enables regulatory authorities to review submissions more efficiently.
The CTD structure and its general principles are defined in the official ICH Common Technical Document guidance.
Organisation of the CTD
The CTD is organised into five modules. Module 1 contains region-specific administrative and prescribing information, while Modules 2–5 follow the harmonised CTD structure.
For a broader overview of the CTD and its electronic submission format, see Common Technical Document and eCTD.
Module 1 – Regional Administrative and Prescribing Information
Contains documents required by the individual regulatory region, such as application forms and proposed prescribing or labelling information.
Module 2 – CTD Summaries
Contains the CTD introduction, Quality Overall Summary, Nonclinical Overview and Summaries, and Clinical Overview and Summary.
Module 3 – Quality
Contains detailed quality information relating to the drug substance and drug product, including manufacturing, controls, specifications, analytical procedures and stability information.
Module 4 – Nonclinical Study Reports
Contains reports and supporting information from relevant pharmacology, pharmacokinetic and toxicology studies.
Module 5 – Clinical Study Reports
Contains clinical study reports and related clinical information supporting the safety and efficacy of the medicinal product.
General Principles of CTD
The CTD should present regulatory information in a clear, organised and consistent manner. Important principles include:
Clarity and Transparency: Information should be presented unambiguously so that reviewers can understand the submitted data and navigate the application efficiently.
Consistency: Information presented across CTD modules should be internally consistent, with appropriate cross-references where necessary.
Harmonised Organisation: Modules 2–5 follow the common ICH structure, reducing the need to reorganise the same technical information for different ICH regulatory authorities.
Region-Specific Requirements: Module 1 is not harmonised internationally. Applicants must follow the administrative and prescribing-information requirements of the regulatory authority receiving the application.
Document Presentation: Text, tables, headings, pagination, abbreviations and references should be presented consistently and clearly to facilitate regulatory review.
CTD Summaries and Supporting Data
An important CTD principle is the relationship between Module 2 and the detailed technical modules.
Module 2 provides summaries and overviews of the supporting information, while Modules 3, 4 and 5 contain the detailed quality, nonclinical and clinical documentation respectively.
For example, the Quality Overall Summary is located in Module 2.3, while the detailed supporting quality information is provided in Module 3.
CTD Principles and Regulatory Review
A well-organised CTD enables reviewers to locate information efficiently and understand the relationship between summaries, analyses and supporting technical documentation.
The CTD therefore provides more than a standard set of modules. Its general principles promote clarity, consistency, transparency and harmonised organisation throughout a regulatory application.
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