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Glossary

MA (Marketing Authorisation)

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Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. 

Other glossary definitions

D

Development safety update report (DSUR)

Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…

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G

Good Clinical Practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…

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