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Regulatory Guidelines

Regulatory Guideline for Central Administration of Pharmaceutical care

Regulatory Guideline For General administration For Regulation of Marketing and Advertising Materials

Type Issue Date Description Issue NO.
Guide line 2015
01
Guide line 2020 Guideline for Prescription Medicine Promotion 01
Guide line 2021 Guidelines for Online Promotional, Educational, Awareness Materials Activities 01
Guide line 2022 الدليل التنظيمي الخاص بالمواد الدعائية لمستحضرات التجميل 01

Regulatory Guideline For General administration For Pharmaceutical References and Leaflets 

Type Issue Date Description Issue NO.
Guide line 2024 Egyptian Guidelines on medical leaflets of medicinal products for Human Use
 04
Guide line 2024 Guideline on E-Labelling of Medical Leaflets of Medicinal and Biological Products for Human Use  02

Regulatory Guideline For General administration For Pharmaceutical Vigilance

Type Issue Date Description Issue NO.
Guide line 2013 The Egyptian Guideline for Medical Device Vigilance System 01
Guide line 2022 Regulatory Guideline of Cosmetics Vigilance 01
Guide line 2022 EDA Cosmetovigilance Guidelines For cosmetic products companies 01
Guide line 2022 Guidance for Implementing the Updated Safety Requirements for Medical Devices in Registration, Re-registration, Variation process and Post-marketing process 01
Guide line 2023 Guideline on Good Pharmacovigilance Practice (GVP) in Egypt
For Pharmaceutical Products
02
Guide line 2023 Guidance Manual for Pharmacovigilance focal points in Healthcare facilities in the Arab Republic of Egypt 01
Guide line 2024 Egyptian Guidelines for Detecting & Reporting of Adverse Reactions For Pharmaceutical products and Medical Devices  04
Guide line 2025 Guideline On Reliance Practices for Pharmacovigilance in Egypt  02
Guide line 2025 The Egyptian Guideline for Medical DeviceVigilanceSystem 01
Guide line 2025 Guidelines for Nitrosamine Impurities in Drug substances and pharmaceutical drug Products 01

Regulatory Guideline For General administration For Drug Utilization and Pharmacy practice

Type Issue Date Description Issue NO.
Guidance 2021 Guidance for Classification as NonPrescription Medicinal Products
(OTC)
01
Guidance 2021 The Egyptian Non-prescription Medicinal Products (OTC) List 01
Guidance 2022 NATIONAL GUIDANCE FOR ANTIMICROBIAL PROPHYLAXIS IN SURGERY

01

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

01

Guidance 2022 National Guidance of Antimicrobial Monitoring

01

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

01

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

01

Guidance 2024 National Guidance for Rational Antifungal Use

01

Guidance 2024

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

 01
Guidance 2024 EDA Diabetes Guidance to Good Pharmacy Practice

01

Guidance 2024

Guidance Drug Therapy Problems and Medication Errors Reference Codes

01

Guidance 2024

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

 01
Guidance 2024

National Guidance for the Rational Use of Duplicate Antimicrobial Therapy

 01
Guidance 2024 National Egyptian Crash Cart and Emergency Medication Lists  01
Guidance 2025 National Guidance of Rational Antimicrobial Use in the Management of Skin and Soft Tissue Infection 01
Guidance 2025 EDA Renal Anaemia Guidance to Good Pharmacy Practice 01
Guidance 2025

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

part 1

01

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