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.
Use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration.
Daily European Union publication publishing legal instruments and other European Union documents.
For more information, see 'Official Journal of the European Union' on the EUR-Lex website.
A European laboratory, independent from pharmaceutical companies, that supports regulatory authorities by controlling the quality of medicinal products for human or veterinary use.
For more information, see 'General European Official Medicines Control Laboratory Network' on the EDQM website.
A presentation and question-and-answer session in person between representatives of an applicant and a European Medicines Agency committee.
A status assigned to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.
More information can be found under 'Orphan designation: Overview'.
A medicine for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Union) or where the medicine is unlikely to generate sufficient profit to justify research and development costs.
More information can be found under 'Orphan designation: Overview'.