Common Technical Document and eCTD
The Common Technical Document and eCTD provide harmonised frameworks for organising and electronically submitting quality, safety and efficacy information for human pharmaceutical regulatory applications. Developed through the International Council for Harmonisation (ICH), the CTD establishes a consistent five-module structure that facilitates preparation and regulatory review across ICH regions.
The electronic Common Technical Document (eCTD) provides a standardised electronic approach for submitting CTD information to regulatory authorities.
Structure of the Common Technical Document
The CTD is organised into five modules. Module 1 contains region-specific information, while Modules 2–5 follow the harmonised CTD structure.
The official CTD structure and supporting guidance are maintained by the International Council for Harmonisation (ICH).
Module 1 – Regional Administrative Information
Module 1 contains administrative and prescribing information required by the relevant regulatory authority. Its content is region-specific and may include application forms, proposed labelling and other administrative documents.
Module 2 – CTD Summaries
Module 2 provides high-level summaries and overviews of the information contained in the technical modules. It includes the Quality Overall Summary, Nonclinical Overview and Summaries, and Clinical Overview and Summary.
Module 3 – Quality
Module 3 contains detailed information concerning the quality of the drug substance and drug product, including manufacturing, characterisation, controls, specifications and stability information.
Module 4 – Nonclinical Study Reports
Module 4 contains reports from nonclinical studies, including relevant pharmacology, pharmacokinetic and toxicology studies.
Module 5 – Clinical Study Reports
Module 5 contains clinical study reports and related clinical information supporting the safety and efficacy of the medicinal product.
For additional background on the CTD framework, see General Principles of CTD.
Electronic Common Technical Document (eCTD)
The eCTD enables applicants to submit CTD information electronically using a harmonised technical structure. It supports efficient navigation, document organisation and lifecycle management of regulatory submissions.
Rather than being simply an electronic copy of a paper CTD, the eCTD provides a structured mechanism for transmitting regulatory information and managing submissions over time.
eCTD Lifecycle Management
Regulatory applications may evolve through multiple submissions after the initial application. The eCTD supports lifecycle management by allowing documents and information to be added, replaced or otherwise managed through subsequent submission sequences.
This helps applicants and regulatory authorities maintain an organised regulatory history throughout the lifecycle of a medicinal product.
eCTD Standards and Regional Implementation
ICH develops and maintains the harmonised technical standards for eCTD. Regional regulatory authorities establish their own implementation requirements, particularly for Module 1 and submission procedures.
Both eCTD v3.2.2 and eCTD v4.0 remain relevant within the global regulatory environment because implementation and transition timelines vary between regulatory regions. Applicants should therefore follow the current requirements of the regulatory authority to which a submission is being made.
The CTD provides the harmonised content structure for regulatory applications, while the eCTD provides the electronic technical framework for submitting and managing that information throughout the regulatory lifecycle.
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