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