Paul-Ehrlich-Institut

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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).

Observational Study

Observational studies (non-interventional studies) are used to gain insights into the use of medicines already authorised, which, unlike clinical trials, are not followed by a pre-defined protocol, but only the medical practice. The examinations are carried out by pharmaceutical companies and also by independent university research groups. In contrast to clinical examinations, there is no requirement for a marketing authorisation by the competent higher federal authorities for application observations, but only an obligation to report to the competent higher federal authority.

Updated: 21.11.2019

Off-Label-Use

Use of a medicine for a non-authorised indication or in a non-autorised age group, dosage, or route of administration.

Updated: 21.11.2019

OMCL Network – Network of Official Medicines Control Laboratories

The European Network of Official Medicines Control Laboratories (OMCL) mutually recognises testing of medicinal products according to jointly established guidelines. It is coordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The Paul-Ehrlich-Institut is part of the network.

Updated: 12.04.2023

Orphan Medicine

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.

Updated: 21.11.2019