Common Technical Document FDA, EMA – CTD Document

Common Technical Document (CTD) is a set of application dossier with specifications for the registration of Medicines and designed to be used & market across different countries Like Europe, Japan and United States (US). CTD Document is an internationally agreed format for the preparation of applications regarding new drugs which are need to be submitted to regional regulatory authorities in participating countries. Mainly, it was developed by the Medical Agencies like European Medicines Agency (EMA in Europe), Food and Drug Administration (FDA in US) and Ministry of Health, Labour and Welfare (Japan). The CTD Document is maintained by the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals Drug for Human Use.

Common Technical Document FDA, EMA – CTD Document

As per the medical agencies, the Common Technical Document is divided into five (5) modules:

CTD Modules:

  • 1 – Module 1 – Administrative & prescribing information
  • 2 – Module 2 – Overview & summary of modules 3 to 5
  • 3 – Module 3 – Quality (Pharmaceutical documentation)
  • 4 – Module 4 – Preclinical (Pharmacology/Toxicology)
  • 5 – Module 5 – Clinical – efficacy and safety (Clinical Trials)

Below you can check the figure of Module Structure of CTD. It will gives you the rough overview and explains about the module of CTD and the phases involved in it:

CTD Document - common technical document FDA
The contents of Module 1 are mostly same for the all the countries. However, certain subheadings of other Modules will differ and it will be based on national requirements.

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

The Paper CTD format has been replaced by its electronic counterpart, which is known as “eCTD“. Previously every Pharmaceuticals Drug registration organization use to submit CTD in paper format. But now it has been changed to electronic format called as Electronic Common Technical Document (eCTD). To register any drug all the pharma companies must submit there documents in eCTD format to their respective health authorities.

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