Glossary

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This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents.

Click on a letter below to see terms beginning with that letter.

Disclaimer: EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.

Glossary

CAT

Committee for Advanced Therapies: the committee that is 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.

For more information, see Committee for Advanced Therapies (CAT).

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 Union. Only certain medicines are eligible for the centralised procedure.

For more information, see central authorisation of medicines.

centrally authorised product

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

For more information, see central authorisation of medicines.

CHMP

Committee for Medicinal Products for Human Use: the committee that is responsible for preparing the Agency's opinions on questions concerning human medicines.

For more information, see Committee for Medicinal Products for Human Use (CHMP).

class waiver

An exemption from the obligation to submit a paediatric investigation plan for a class of medicines, such as medicines for diseases that only affect adults. Class waivers are adopted by the Paediatric Committee (PDCO).

For more information, see class waivers.

clinical trial

A study performed to investigate the safety or 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 Procedures - Human: 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.

For more information, see Coordination Group for Mutual Recognition and Decentralised Procedures - Human.

CMDv

Coordination Group for Mutual Recognition and Decentralised Procedures - 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.

For more information, see Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary.

co-rapporteur

One of the two members of a committee or working party leading the assessment of an application.

commercially confidential information

Information whose publication might prejudice the commercial interests of individuals or companies to an unreasonable degree. The Agency cannot disclose commercially confidential information unless there is an overriding public interest in disclosure.

For more information, see Principles to be applied for the deletion of commercially confidential information for the disclosure of European Medicines Agency documents.

Committee for Advanced Therapies

The committee that is 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. Abbreviated as CAT.

For more information, see Committee for Advanced Therapies (CAT).

Committee for Medicinal Products for Human Use

The committee that is responsible for preparing the Agency's opinions on questions concerning human medicines. Abbreviated as CHMP.

For more information, see Committee for Medicinal Products for Human Use (CHMP).

Committee for Medicinal Products for Veterinary Use

The committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines. Abbreviated as CVMP.

For more information, see Committee for Medicinal Products for Veterinary Use (CVMP).

Committee for Orphan Medicinal Products

The committee that is responsible for reviewing applications for orphan designation for medicines that are intended for the diagnosis, prevention or treatment of rare diseases. Abbreviated as COMP.

For more information, see Committee for Orphan Medicinal Products (COMP).

Committee for Proprietary Medicinal Products

The name of the Committee for Medicinal Products for Human Use until May 2004.

For more information, see Committee for Medicinal Products for Human Use (CHMP).

Committee on Herbal Medicinal Products

The committee that is responsible for establishing Community herbal monographs and preparing the Agency’s opinions on questions relating to herbal medicines. Abbreviated as HMPC.

For more information, see Committee on Herbal Medicinal Products (HMPC).

common technical document

A common format for submitting scientific information when applying for marketing authorisations in the European Union, Japan and the United States.

For more information, see M4 : The common technical document.

COMP

Committee for Orphan Medicinal Products: the committee that is responsible for reviewing applications for orphan designation for medicines that are intended for the diagnosis, prevention or treatment of rare diseases.

For more information, see Committee for Orphan Medicinal Products (COMP).

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.

For more information, see compassionate use.

competent authority

A medicines regulatory authority in the European Union.

concept paper

A document prepared by a European Medicines Agency working party prior to the drafting of a guideline, setting out the problem, the scope of the work, the resources needed and the timeframe.

For more information, see procedure for European Union guidelines and related documents within the pharmaceutical legislative framework.

concerned Member State

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.

For more information, see volume 2A: Procedures for marketing authorisation: Chapter 2: Mutual recognition.

conditional marketing authorisation

The approval of a medicine that address 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.

For more information, see conditional marketing authorisation

Coordination Group for Mutual Recognition and Decentralised Procedures - Human

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. Abbreviated as CMDh.

For more information, see Coordination Group for Mutual Recognition and Decentralised Procedures - Human.

Coordination Group for Mutual Recognition and Decentralised Procedures - 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. Abbreviated as CMDv.

For more information, see Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary.

counterfeit medicine

A medicine made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or rights. Counterfeit medicines infringe trademark law.

For more information, see falsified medicines.

CVMP

Committee for Medicinal Products for Veterinary Use: the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

For more information, see Committee for Medicinal Products for Veterinary Use (CVMP).