Medical terms simplifier
EMA’s medical terms simplifier gives plain-language descriptions of medical terms commonly used in information about medicines:
The resource focuses on side effects and other terms used in medicines information and assessments of medicines.
The medical terms simplifier does not cover rarely used terms, most disease states, very specialised areas or the broader field of medical science. EMA will issue updates of the document.
Glossary of regulatory terms
EMA's glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in 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.
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.
More information can be found under 'Committee for Advanced Therapies (CAT)'.
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.
More information can be found under 'Authorisation of medicines'.
A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union.
More information can be found under 'Authorisation of medicines'.
Committee for Medicinal Products for Human Use: the committee that is responsible for preparing the Agency's opinions on questions concerning human medicines.
More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.
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).
More information can be found under 'Class waivers'.
A study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.
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.
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.
More information can be found under 'Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)'.
Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv): 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.
More information can be found under 'Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)'.
One of the two members of a committee or working party leading the assessment of an application.
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.
More information can be found in the 'Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework'.
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.
More information can be found under 'Committee for Advanced Therapies (CAT)'.
The committee that is responsible for preparing the Agency's opinions on questions concerning human medicines. Abbreviated as CHMP.
More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.
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.
More information can be found under 'Committee for Orphan Medicinal Products (COMP)'.
The name of the Committee for Medicinal Products for Human Use (CHMP) until May 2004.
More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.
The committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines. Abbreviated as CVMP.
More information can be found under 'Committee for Veterinary Medicinal Products (CVMP)'.
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.
More information can be found under 'Committee on Herbal Medicinal Products (HMPC)'.
A common format for submitting scientific information when applying for marketing authorisations in the European Union, Japan and the United States.
More information can be found on ICH's website under 'M4 : The common technical document'.
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.
More information can be found under 'Committee for Orphan Medicinal Products (COMP)'.
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.
More information can be found under 'Compassionate use'
A medicines regulatory authority in the European Union.
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.
More informationcan be found in the 'Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework'.
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.
More information can be found in 'Volume 2A: Procedures for marketing authorisation: Chapter 2: Mutual recognition'.
The approval of 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.
More information can be found under 'Conditional marketing authorisation'.
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.
More information can be found under '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 veterinary medicines in two or more Member States in accordance with the mutual-recognition or decentralised procedure. Abbreviated as CMDv.
More information can be found under 'Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)'.
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.
More information can be found under 'Falsified medicines: overview'.
Committee for Veterinary Medicinal Products (CVMP): the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.
More information can be found under 'Committee for Veterinary Medicinal Products (CVMP)'.