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The Regulatory Reference of the Egyptian Drug Authority (EDA)

Guidance

Regulatory Guideline For General administration For Pharmacovigilance  

Issue Date

Description

Issue NO.

2022 Regulatory Guideline of Cosmetics Vigilance 01
2022 Guidance for Implementing the Updated Safety Requirements for Medical Devices in Registration, Re-registration, Variation process and Post-marketing process 01
2023 آلية العمل الخاصة بالإدارة العامة لليقظة الصيدلية بشأن تنظيم قواعد وإجراءات تسجيل / إعادة التسجيل المستحضرات المبتكرة 01
2023 دليل إرشادي للممارسة الجيدة لليقظة للمستحضرات الطبية والحيوية 02
2023

Guidance manual for reporting adverse drug reactions (For patients)

Arabic version

01
2023 Guidance Manual for Pharmacovigilance focal points in Healthcare facilities in the Arab Republic of Egypt 01
2023 كتيب إرشادات لمسئولي اليقظة الدوائية في المؤسسات الصحية في جمهورية مصر العربية 01
2024 Egyptian Guidelines for Detecting & Reporting of Adverse Reactions For Pharmaceutical products and Medical Devices 04

 

 

 

Regulatory Guideline For General administration For Drug Utilization and Pharmacy practice

Issue Date Description Issue NO.
2022 NATIONAL GUIDANCE FOR ANTIMICROBIAL PROPHYLAXIS IN SURGERY

01

2022 NATIONAL GUIDANCE FOR SWITCHING ANTIBIOTICS FROM IV TO ORAL 01
2022 Egyptian Guidance for Oncology Pharmacy Practice 01
2022 National Guidance for Preauthorization of Restricted
Antimicrobials in hospitals National Antimicrobial Rational Use Committee

01

2022 National Guidance of Antimicrobial Monitoring

01

2023 Egyptian Guidance for Oncology Pharmacy PracticeVolume II
Chapter 1 -Biologics and Biosimilars
01
2023 National Guidance for Non-Surgical Antimicrobial
Prophylaxis

01

2024 Egyptian Guidance for Oncology Pharmacy Practice
Volume II, Chapter II
Nuclear and Radiological Safety Principles and Practice
of Nuclear Pharmacy

01

2024 National Guidance for Rational Antifungal Use

01

2024

National Guidance for Antimicrobial Use in Infections with
Multi-Drug Resistant Organisms (MDROs)

 01
2024 EDA Diabetes Guidance to Good Pharmacy Practice

01

2024

Guidance Drug Therapy Problems and Medication Errors Reference Codes

01

2024

Egyptian Guidance for Oncology Pharmacy Practice
Volume II
Chapter III
Role of Oncology Pharmacist in Radiotherapy

 01
2024

National Guidance for the Rational Use of Duplicate Antimicrobial Therapy

 01
2025 National Guidance of Rational Antimicrobial Use in the Management of Skin and Soft Tissue Infection 01
2025 EDA Renal Anaemia Guidance to Good Pharmacy Practice 01
2025

Egyptian Guidance for Oncology Pharmacy Practice
Pharmacist’s Role in Personalized Medication Management

part 1

01

 

 

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