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Guideline Name: Clinical Trial AuthorizationETHIOPIAN FOOD AND DRUG AUTHORITYPharmacovigilance and Clinical Trial Lead Executive Office Guideline for Clinical Trial Authorization Document No. EFDA/GDA/005
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Clarification of requirements under refers to the process of seeking additional details or explanations regarding specific regulations or obligations that need to be fulfilled.
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Typically, organizations or individuals who are subject to specific regulatory requirements or obligations must file clarification of requirements under.
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Information that must be reported typically includes the entity's identification details, specific requirements in question, and any relevant supporting documentation.
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