Paul-Ehrlich-Institut

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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.

Updated: 27.04.2023

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.

Updated: 27.04.2023

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.

Updated: 27.04.2023

Centrally Authorised Product

A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union.

Updated: 27.04.2023

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.

Updated: 27.04.2023

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.

Updated: 21.11.2019

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.

Updated: 21.11.2019

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.

Updated: 27.04.2023

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.

Updated: 27.04.2023

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.

Updated: 27.04.2023

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.

Updated: 27.04.2023

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.

Updated: 21.11.2019

Competent Authority

A medicines regulatory authority in the European Union.

Updated: 21.11.2019

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.

Updated: 21.11.2019

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.

Updated: 27.04.2023

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.

Updated: 15.01.2024

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).

Updated: 12.04.2023

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.

Updated: 27.04.2023