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ISSN 23953411Available online at www.ijpacr.com369 Review ArticleComparison of Regulatory Requirements for Generic Drugs Dossier Submission in the United States, Europe and Canada Syed Moment* Department
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What is comparison of regulatory requirements?
Comparison of regulatory requirements is the process of identifying and comparing the regulations and requirements applicable to a specific industry or activity.
Who is required to file comparison of regulatory requirements?
Entities or individuals engaged in regulated activities are required to file comparison of regulatory requirements.
How to fill out comparison of regulatory requirements?
Comparison of regulatory requirements can be filled out by reviewing the relevant regulations, identifying the differences and similarities, and documenting them in a report.
What is the purpose of comparison of regulatory requirements?
The purpose of comparison of regulatory requirements is to ensure compliance with all relevant regulations, identify areas of overlap or conflict, and streamline regulatory processes.
What information must be reported on comparison of regulatory requirements?
Information such as the specific regulations applicable, differences between regulations, potential conflicts, and proposed solutions must be reported on comparison of regulatory requirements.
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