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.
Information on the immediate or outer packaging of a medicine.
A set of questions addressed to a company during a procedure, such as the evaluation of a marketing authorisation application. Lists of outstanding issues are prepared after a company has already responded to a list of questions.
A set of questions addressed to a company during a procedure, such as a marketing authorisation application.