GUIDELINE ON Content File of Biological Products for Registration & Re-registration file
Guideline for Lot Release of Biological Products
الإجراءات الخاصة بقواعد تسجيل المستحضرات الحيوية بنظام الاعتماد على السلطات الصحية المرجعية
Procedures for Registration of Biological products through Reliance pathways
2022
List of documents submitted for EDA Approval Renewal of CT protocol
List of required documents for protocol amendment reliance submission to Bio Inn-EDA for CT
List of required documents for protocol reliance submission to Bio Inn-EDA for CT in Egypt
List of required documents to be submitted in case of Amendment
List of Required Documents in the Preclinical Package to be submitted to Bio Inn EDA for Scientific Opinion before First in Human Clinical Trial
List of the required documents to be submitted to Bio Inn EDA for clinical trials in Egypt
Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority ( V2)
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