Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
Bioavailability
The extent to which an active ingredient is absorbed from a medicine and becomes available in the body.
BIÖG – Bundesinstitut für Öffentliche Gesundheit
Federal Institute for Public Health (Bundesinstitut für Öffentliche Gesundheit, BIÖG): More health for the citizens is the goal to which the BIÖG is committed. As a specialist authority for health promotion, it develops strategies for health education and prevention, together with cooperation partners, and implements them in campaigns and projects.
Biomarker
A biological molecule found in blood, other body fluids, or tissues that can be used to follow up body processes and diseases in humans and animals.
Biomedicine
A biological medicinal product is a medicinal product whose active substance is of biological origin or derived from biological source material.
Biosimilar Medicine
A biosimilar medicine ("biosimilar") is a medicine which is very similar to another biological medicine already marketed in the EU (the so-called reference medicine).
Biotechnology
The use of living organisms to create or modify products, including medicines.
Black Triangle
Since 2013, medicines under additional surveillance are marked with a black triangle in all EU Member States. Additional monitoring is usually done because there is less information available to them than to other medicines. The reasons may be because the product is new to the market or because there is insufficient data on its long-term use. The black triangle indicates that this product is being monitored even more strictly than other medicines. It does not mean that the medicine is not safe.
BMG – Bundesministerium für Gesundheit
Federal Ministry of Health (Bundesministerium für Gesundheit, BMG): The Federal Ministry of Health is responsible for a variety of policy areas at its headquarters in Bonn and at its headquarters in Berlin. The work focuses on preparing draft laws, ordinances and administrative regulations.