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Glossary

Redaction

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In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. The redaction should appear as a light blue box with a black ‘PPD’ label or as a black box with a red ‘CCI’ label.

Other glossary definitions

C

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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H

Health Technology Assessment

HTA is a multidisciplinary process that summarises information about the medical, social, economic, and ethical…

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