Glossary · ICH guidelines
Common Technical Document (CTD, ICH M4)
Also known as: CTD, ICH M4, eCTD, Common Technical Document
The Common Technical Document (CTD), defined in ICH guideline M4, is the harmonized format for the quality, nonclinical and clinical information in marketing authorization applications for medicines. It is organized in five modules; module 1 holds regional administrative information, modules 2 to 5 are common across ICH regions.
- ICH
- Pharma
- Technical documentation
In one sentence
The CTD (ICH M4) is the five-module format for medicines marketing applications: regional data, summaries, quality, nonclinical and clinical reports.
Example
A company submits the same modules 2 to 5 for a new tablet to EMA and FDA, with an EU-specific module 1 (application form, product information) and a US-specific module 1, both in eCTD format.
How it applies
- Module 1: Regional administrative information, such as application forms and proposed product information; not part of the harmonized CTD.
- Module 2: Summaries and overviews, including the quality overall summary and the nonclinical and clinical overviews and summaries.
- Module 3: Quality (chemistry, manufacturing and controls) for the drug substance and drug product, including pharmaceutical development and analytical procedures.
- Modules 4 and 5: Nonclinical study reports and clinical study reports.
- eCTD: The electronic format of the CTD, used for submissions to EMA, FDA and other regulators; the structure of the content is the same.
- Technical documentation: Write module 3 content so it can be maintained over the lifecycle: identify established conditions, keep versions under document control and trace each statement to source reports.
CTD vs. MDR technical documentation
The CTD is submitted to a medicines regulator for a marketing authorization. Technical documentation under the MDR and IVDR follows Annexes II and III, is kept by the manufacturer and assessed by a notified body where one is involved, and is not submitted in CTD format. For an integral drug-device combination regulated as a medicinal product, the device part's conformity is addressed within the CTD under MDR Article 117.