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Glossary

Committee for Advanced Therapy (CAT)

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The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.

The committee’s main responsibility is to prepare a draft opinion on each ATMP application submitted to EMA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorization of the medicine concerned.

Other glossary definitions

C

Company Core Data Sheet (CCDS)

A document prepared by the marketing authorization holder containing, in addition to safety information, material…

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S

Suspected Unexpected Serious Adverse Reaction (SUSAR)

In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical…

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