Glossary

  • Email
  • Help

This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents.

Click on a letter below to see terms beginning with that letter.

Disclaimer: EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.

Glossary

gene-therapy medicine

A medicine that delivers genes into the body.

For more information, see advanced therapies.

generic medicine

A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorised. Its authorisation is based on efficacy and safety data from studies on the authorised medicine. A company can only market a generic medicine once the 10-year exclusivity period for the original medicine has expired.

For more information, see generic medicines.

good agricultural and collection practice

A set of standards for the collection, cultivation, harvest and primary processing of plant materials for use in herbal medicines. Abbreviated as GACP.

For more information, see guideline on good agricultural and collection practice for starting materials of herbal origin.

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 a study’s results are credible and accurate and that the rights and confidentiality of the study subjects are protected. Abbreviated as GCP.

For more information, see good-clinical-practice compliance.

good distribution practice

A code of standards ensuring that the quality of a medicine is maintained throughout the distribution network, so that authorised medicines are distributed to retail pharmacists and others selling medicines to the general public without any alteration of their properties. Abbreviated as GDP.

For more information, see good-manufacturing-practice and good-distribution-practice compliance.

good laboratory practice

A code of standards concerning the testing of medicines in laboratories during their development. Abbreviated as GLP.

For more information, see good-laboratory-practice compliance.

good manufacturing practice

A code of standards concerning the manufacture, processing, packing, release and holding of a medicine. Abbreviated as GMP.

For more information, see good-manufacturing-practice and good-distribution-practice compliance.

good pharmacovigilance practice

A set of measures drawn up to facilitate the performance of the safety monitoring of medicines in the European Union. Abbreviated as GVP.

For more information, see good pharmacovigilance practices.

grouping

The possibility for a marketing authorisation holder to submit more than one variation for a medicine in a single application.

For more information, see grouping of variations: questions and anwers.

guideline

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

For more information, see scientific guidelines and procedure for European Union guidelines and related documents within the pharmaceutical legislative framework.