Common Technical Documents, often known as CTDs, are crucial collections of data for a new medicine that comprise the application dossier. Before the drug may go through clinical trials and later be launched to the market, the application dossier is then filed with the intention of receiving permission from local regulatory authorities.

These regional regulatory agencies include the Ministry of Health, Labour and Welfare for Japan, the European Medicines Agency for Europe, and the Food and Drug Administration for the United States of America.

Application dossiers for new medications must be created in accordance with a format that is globally accepted before regulatory authorities can receive and review them. The International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use is in charge of implementing this standardized format for CTDs.

Each CTD is segmented into 5 modules:

  1. Regional Administrative and prescribing information
  2. Overview and summary of pharmaceutical drugs
  3. Quality (pharmaceutical documentation)
  4. Pre-clinical (Pharmacology/Toxicology)
  5. Clinical (Efficacy and Safety)

Benefits offered by CTD are:

  1. Medical products are registered in a well-defined and cost-effective manner
  2. Establishing a harmonized standard for new product submissions for marketing permits
  3. Facilitating successful submission lifecycle management for a variety of products.