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 International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry. It makes recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration.
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.
A document providing information related to an individual case of a suspected side effect due to a medicine.
An application where the reference medicine's marketing authorisation holder has consented to the use of the reference medicine's data for the application.
A medicine that contains an active substance or combination of active substances that has not been authorised before.
The date of the first marketing authorisation for a medicine in any country in the world.
The globally recognised name used to identify the active ingredient in a medicine. Abbreviated as INN.
For more information, see international non-proprietary names.
The trade name of a medicine. Invented names need to be approved by the Agency’s Name Review Group.
A medicine being studied in a clinical trial.