Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
CAR-T Cells - Chimeric Antigen Receptor T Cells
Immune cells of the patient (T cells) with an altered antigen receptor (chimeric antigen receptor, CAR), which makes it possible to recognise and fight cancer cells.
CAT - Committee for Advanced Therapies
Committee for Advanced Therapies of the EMA: the committee responsible for assessing the quality, safety and efficacy of advanced-therapy medicines, including medicines classified as gene therapy, somatic-cell therapy or tissue-engineered products.
Centralised Procedure
The European Union-wide procedure for the authorisation of medicines, where there is a single application, a single evaluation and a single authorisation throughout the European Economic Area. Only certain medicines are eligible for the centralised procedure.
Centrally Authorised Product
A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union.
CHMP - Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP); Committee for Medicinal Products for Human Use of the EMA: The committee responsible for preparing the scientific opinions of the European Medicines Agency on applications for marketing authorization for medicinal products in the centralized procedure and questions relating to medicinal products for human use.
Clinical Trial
A study performed to investigate the safety and efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.
Clock Stop
A period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.
CMDh - Coordination Group for Mutual Recognition and Decentralised Procedure - Human
Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh): the group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure.
CMDv - Coordination Group for Mutual Recognition and Decentralised Procedure - Veterinary
Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv): Veterinary: the group responsible for the examination and coordination of questions relating to the marketing authorisation of veterinary medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure.
CMS - Concerned Member State
Concerned Member State (CMS): A European Economic Area country in which an application has been submitted for authorisation of a medicine through the mutual recognition or decentralised procedure. The assessment of the medicine is performed by another country called the reference Member State.
COMP - Committee for Orphan Medicinal Products
Committee for Orphan Medicinal Products (COMP): the committee responsible for reviewing applications for orphan designation for medicines intended for the diagnosis, prevention or treatment of rare diseases.
Compassionate Use
The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.
Competent Authority
A medicines regulatory authority in the European Union.
Conditional Marketing Authorisation
The marketing authorisation for a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.
Counterfeit Medicine
According to the World Health Organization (WHO) a medicine that has been fraudulently misidentified. This means that the identity, ingredients and/or origin are misrepresented.
CRISPR/Cas (Genetic Scissors)
CRISPR/Cas (Clustered Regularly Interspaced Short Palindromic Repeats and CRISPR-associated protein) is an RNA-protein complex that enables a molecular biological process in which a DNA strand is severed at a predetermined location in order to make targeted changes at that location. DNA (deoxyribonucleic acid) contains the cell's genetic information. This intervention can change the genetic information of a cell by deliberately inserting, removing or modifying individual DNA components.
CTIS – Clinical Trials Information System
The Clinical Trials Information System (CTIS) is the European information system for clinical trials operated by the European Medicines Agency (EMA).
CVMP - Committee for Medicinal Products for Veterinary Use
Committee for Medicinal Products for Veterinary Use (CVMP): the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.