Wednesday, 5 October 2022, 1:45 AM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
C

Committee for Orphan Medicinal Products

Committee for Proprietary Medicinal Products

Committee for Veterinary Medicinal Products

Committee on Herbal Medicinal Products

Common European Submission Platform

Common European Submission Platform (CESP) http://cesp.hma.eu"

Common Technical Document

The Common Technical Document (CTD) is an internationally agreed format for the preparation of marketing applications to regulatory authorities for new medicines approval. The CTD is divided into five modules, where modules 2 to 5 constitute the actual CTD and module 1 differs according to the region. The modules are:

  1. Administrative and prescribing information (these contents might differ based on national requirements),
  2. Overview and summary of modules 3 to 5,
  3. Quality (pharmaceutical documentation),
  4. Non-clinical study reports (pharmacology/toxicology),
  5. Clinical study reports“ efficacy and safety (clinical trials).

Community Advisory Board

Community Advisory Board

Compassionate use

Method of providing an unlicensed medicine prior to final approval by a regulatory (competent) authority for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained for compassionate use of a medicine or therapy.

Competent Authority

Competent Authority

Complementary DNA

Complementary DNA