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.
The measurement of a medicine's desired effect under ideal conditions, such as in a clinical trial.
A common technical document in electronic format. Abbreviated as eCTD.
For more information, see the eSubmission website's section on eCTD.
Analysis of the potential risk that the use of a medicine poses to the environment.
A database that includes information on clinical trials taking place in the European Union and clinical studies conducted worldwide in accordance with a paediatric investigation plan. A subset of the data is publicly accessible via the European Clinical Trials Register.
For more information, see the EudraCT website.
The European Drug Regulatory Network: a secure communication infrastructure linking European medicines regulatory authorities.
Eudrapharm was an online database of human medicines approved in the European Union (EU). It was decommissioned in June 2019.
A list of all human medicines approved in the EU can be found under 'Public data from Article 57 database'.
A centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA).
More information can be found under 'EudraVigilance'.
The European Union reference dates (EURD) list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates, frequencies for submission of periodic safety update reports and related data lock points.
More information is available under 'Periodic safety update reports'.
The legally binding decision issued by the European Commission at the end of a regulatory procedure, such as a marketing authorisation application or arbitration procedure. A European Commission decision comes after an opinion from one of the Agency’s scientific committees.
For more information, see the European Commission's section on European Union centralised procedures.
The system for regulating medicines in Europe is based on a closely coordinated regulatory network of national competent authorities in the Member States of the European Economic Area working together with the European Medicines Agency and the European Commission.
More information can be found under 'European medicines regulatory network'.
A network of European centres in the fields of pharmacoepidemiology and pharmacovigilance, which aims to strengthen the postauthorisation monitoring of medicines by facilitating the conduct of multicentre, independent, postauthorisation studies focusing on safety and on benefit-risk balance. It is coordinated by the European Medicines Agency. Abbreviated as ENCePP.
For more information, see the ENCePP website.
A network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Abbreviated as Enpr-EMA.
More information can be found under 'European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)'.
A compendium of texts on the qualitative and quantitative composition of medicines, and on the tests to be carried out on medicines, on the raw materials used in the production of medicines and on the intermediates of synthesis.
For more information, see the European Pharmacopoeia on the Council of Europe website.
A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information. Abbreviated as EPAR.
More information can be found under 'European public assessment reports: background and context'.
An electronic tool for the receipt, validation, storage and provision of electronic documents for marketing authorisation applications and postauthorisation applications. Abbreviated as EURS.
For more information, see the eSubmission website's section on EURS.
A website that contains public information on interventional clinical trials on medicines.
For more information, see the European Union Clinical Trials Register.
The scientific opinion of the Committee on Herbal Medicinal Products on the efficacy, safety and recommended uses of a medicine containing a herbal substance or a herbal preparation.
More information is available under 'European Union monographs and list entries'.
A type of marketing authorisation granted to medicines where the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the condition to be treated is rare or because collection of full information is not possible or is unethical.
More information is available under 'Pre-authorisation guidance: question 1.10'.
A constituent of a medicine other than the active substance.