Paul-Ehrlich-Institut

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

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).

G-BA - Gemeinsamer Bundesausschuss

Gemeinsamer Bundesausschuss (G-BA, Joint Federal Committee): The G-BA is the supreme decision-making body of self-government in health care and decides, for example, the costs for which medical services are taken over by the statutory health insurance funds.

Updated: 25.05.2023

GCP - Good Clinical Practice

GCP - Good Clinical Practice: A code of international standards concerning the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. Good clinical practice provides assurance that the results of a study are credible and accurate and that the rights and confidentiality of the study subjects are protected.

Updated: 24.05.2023

Gene Therapy

A gene therapy is a biological drug whose active ingredient contains or consists of a nucleic acid (carrier of genetic information). It is used to regulate, repair, replace, add or remove a nucleic acid sequence.

Updated: 21.11.2019

GLP - Good Laboratory Practice

Good Laboratory Practice (GLP) is a code of standards concerning the testing of medicines in laboratories during their development; abbreviated as GLP.

Updated: 24.05.2023

GMP - Good Manufacturing Practice

Good Manufacturing Practice (GMP) - A code of standards concerning the manufacture, processing, packaging, release and storage of a medicine.

Updated: 24.05.2023

Guideline

A document providing guidance on the scientific or regulatory aspects of the development of medicines and applications for a marketing authorisation. Although guidelines are not legally binding, applicants need to provide justification for any deviations.

Updated: 21.11.2019