Egyptian Guidelines on CTD Quality Module for Human Pharmaceuticals
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This guidance outlines the required documents and references for preparing the CTD Quality Module, in line with Egyptian regulations. EDA may request additional data or refer to other international guidelines to ensure product quality, safety, and efficacy.
Guidelines for Mock-up Design of Human Pharmaceutical Products
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The EDA issues this guidance to outline labeling and design requirements for 1ry and 2ry packaging of human medicinal products.
Guidelines on Human Pharmaceuticals Variations
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The updated Variation Guidelines align with international standards, expand change classifications, and define risk levels.