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).
ADE - Antibody Dependent Enhancement
Antibody Dependent Enhancement (ADE) occur when antibodies bind to the surface of viruses, but do not neutralise them. Instead, they make it easier for the virus to enter the cell and increase the infection. For example, ADE has been observed in infections with the dengue virus.
Adjuvant
An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s immune response.
Adverse Event
An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.
Adverse Reactions
Adverse reactions are noxious and unintended reactions to the medicinal product, according to section 4 paragraph 13 of the Medicinal Products Act (Arzneimittelgesetz, AMG).
It does not matter whether the adverse reaction occurred during use in keeping with the intended purpose - i.e. according to the instructions in the package leaflet or the summary of product characteristics - or whether the adverse reaction involved an overdose, a medication error, abuse, or misuse or occurred within the scope of occupational exposure.
Albumine
Albumins are proteins (proteins) which are among other things contained in the blood plasma. Human albumins are referred to as human albumins.
Allergene
An allergen is a substance which can trigger hypersensitivity reactions of the immune system thus causing allergies.
AMG - Arzneimittelgesetz
The German Medicinal Products Act (Arzneimittelgesetz, AMG) is intended to "ensure the safety relating to the marketing of medicines, in particular for the quality, efficacy and safety of the medicines in the interest of a proper supply of medicines for humans and animals" (§1 AMG).
ATMP - Advanced Therapy Medicinal Product
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.
Authorisation Procedure
The marketing authorisation procedure checks whether a medicinal product is effective, harmless, and of the required pharmaceutical quality. The necessary registration documents will be submitted by the pharmaceutical company that intends to market the medicine.