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.
The extent to which an active ingredient is absorbed from a medicine and becomes available in the body.
When two medicines release the same active ingredient into the body at the same rate and to the same extent under similar conditions.
A medicine whose active substance is made by a living organism.
An objective and quantifiable measure of a physiological process, pathological process or response to a treatment (excluding measurements of how an individual feels or functions).
More information can be found under 'Qualification of novel methodologies for medicine development'.
Certification of the acceptability of a biomarker for a specific use in pharmaceutical research and development. The Agency gives opinions on biomarker qualifications.
More information can be found under 'Qualification of novel methodologies for medicine development'.
A medicine that is similar to a biological medicine that has already been authorised.
More information can be found under 'Biosimilar medicines: Overview'.
The use of living organisms to create or modify products, including medicines.