Glossary

Node Extension

Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the eCTD structure and should be displayed as such when the XML backbone is viewed.

Source: EMA PRACTICAL GUIDELINES FOR PLASMA MASTER FILE HOLDERS (PMF-H) ON THE eCTD FORMAT

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Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.