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.
Glossary
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.
Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…
View definitionAs defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…
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