Common Technical Document

The 'Common Technical Document' or 'CTD' is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMEA, Europe), the Food and Drug Administration (FDA, USA) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).^[1]

1. Administrative and prescribing information
2. Overview and summary of modules 3 to 5
3. Quality (pharmaceutical documentation)
4. Safety (toxicology studies)
5. Efficacy (clinical studies)

Additional recommended knowledge

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Detailed subheadings for each Module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of other Modules will differ, based on national requirements.

After USA, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.

The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD.

See also

• Harmonization in clinical trials
• eCTD
• Clinical Data Interchange Standards Consortium
• Clinical trial

References