• Source: Common Technical Document

      • The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond.


      Major Synopsis


      The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989.
      The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
      After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada and Switzerland.
      Paper CTDs are destined for replacement by their electronic counterparts, the eCTDs.


      Contents


      The Common Technical Document is divided into five modules:

      Administrative and prescribing information
      Overview and summary of modules 3 to 5
      Quality (pharmaceutical documentation)
      Preclinical (pharmacology/toxicology)
      Clinical – efficacy and safety (clinical trials)
      Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements.


      See also


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


      References




      External links


      ICH
      Common Technical Document

    Kata Kunci Pencarian: