Glossary

Committee for Orphan Medicinal Products (COMP) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp"

Committee for Proprietary Medicinal Products (CPMP) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp"

Committee at the European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000262.jsp"

Committee on Herbal Medicinal Products (HMPC) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000264.jsp"

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

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

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.

Complementary DNA