Regulatory Guidelines for the General Administration Of Pharmaceutical products registration
guideline for Bioavailability and Bioequivalence studies:
| Type | Issue date | description | Issue No. |
| Guide line | 06-2026 | Egyptian Guideline for Conducting Bioequivalence Studies for Marketing Authorization of Generic |
04 |
guideline for Naming and mockup of Human Pharmaceutical product
| Type | Issue date | description | Issue No. |
| Guide line | May-2023 | Guidelines on mock-up Design of Human Pharmaceutical Products 2023 | 03 |
| Guide line | Apr-2024 | GUIDELINES ON Naming of Human Pharmaceutical Products | 04 |
guideline For variation of Human Pharmaceutical product
| Type | Issue date | description | Issue No. |
| Guide line | Dec-2025 | Guidelines For Human Pharmaceuticals Variations | 06 |
guideline For Registration Of Human pharmaceutical products
Regulatory Guidelines for the General Administration Of Veterinary Pharmaceuticals
| Type | Issue date | description | Issue No. |
| Guide line | 10/2023 | Guidelines on Procedures for Re-registering Veterinary Pharmaceuticals According to the Chairman of Egyptian Drug Authority’s Decision No. (434) of 2022 |
02 |
| Guide line | 02/2024 |
01 |
|
| Guide line | 03/2024 | Guideline of Registering Veterinary Pharmaceuticals Imported from Reference Countries According to the Fast Track Registration System |
03 |
| Guide line | 10/2024 | Guidelines on Naming of Veterinary Pharmaceuticals | 05 |
| Guide line | 08/2025 | Guidelines on Registration Procedures of Veterinary Pharmaceuticals According to the Chairman of Egyptian Drug Authority’s Decision No. 625 Year 2024 | 02 |
| Guide line | 01/2026 | Egyptian Guidelines for Conducting Bioequivalence Studies for Generic Veterinary Medicinal Products | 01 |
| Guide line | 03/2026 | Guidelines for the update of the mechanism of addition/ transfer of manufacturing site of registered local human and veterinary medicinal products | 03 |
Regulatory Guidelines for the General Administration For Herbal Medicinal products registration
| Type | Issue date | description | Issue No. |
| Guide line | Aug-21 | Egyptian Guidelines for Registration of Herbal Medicines | 02 |
| Guide line | Sep-21 | Executive Procedures of Reviewing the Cards of Herbal Medicine Products |
01 |
| Guide line | Sep-21 | Executive Procedures of Reviewing the Names of Herbal Medicine Products |
01 |
| Guide line | Nov-2025 | 02 | |
| Guide line | Nov-2025 |
Executive Procedures for Regulating Registration/Re-registration |
04 |
Regulatory Guidelines for the General Administration For Cosmetic products registration
| Type | Issue date | description | Issue No. |
| Guide line | 6-Mar-2022 | Regulatory Guide for Cosmetics Notification | 01 |
| Guide line | 14-Apr-2025 | Claims Guide for Cosmetics Notification | 05 |
| Guide line | 04-Aug-2025 | Documents Required for Variations of Cosmetic Products | 01 |
Regulatory Guidelines for the General Administration Of Biocides registration
| Type | Issue date | description | Issue No. |
| Guide line | Feb-2025 | Regulatory and Guidance Guideline and Business Rules for Antiseptics/Disinfectants Registration |
03 |
| Guide line | Feb-2025 | Regulatory Guidelines and Work Rules for the Registration of Pesticides | 03 |