Browsing Magister Pharmaceuticae - MPharm by Subject "Post-approval change"
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Risk based approach of post- approval changes in central America and Dominican republic, identifying opportunities for convergence with EMA and FDA
(University of Western Cape, 2021)In Central American countries (Guatemala, El Salvador, Honduras, Nicaragua, Costa Rica and Panama) and Dominican Republic (DR) the approval timelines for major changes are described ranging from 12 to 18 months, these ...