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Rev. July 16, 2019Contents
INTRODUCTION TO TNA .........................................................................................................4
WELCOME .....................................................................................................................
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What is common technical document module?
Common Technical Document Module is a standardized format for submitting documentation required for pharmaceutical product registration.
Who is required to file common technical document module?
Pharmaceutical companies seeking product registration are required to file the Common Technical Document Module.
How to fill out common technical document module?
Common Technical Document Module is typically filled out by including information on drug development, quality, safety, and efficacy.
What is the purpose of common technical document module?
The purpose of the Common Technical Document Module is to provide regulatory authorities with comprehensive information about the pharmaceutical product.
What information must be reported on common technical document module?
Information such as drug development data, manufacturing processes, quality control measures, clinical trial results, and safety profiles must be reported on the Common Technical Document Module.
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