Regulatory Guidelines for the central Administration For Pharmaceutical products

Regulatory Guidelines for the General Administration For Pharmaceutical products registration

guideline for Bioavailability and Bioequivalence studies:

Type	Issue date	description	Issue No.
Guide line	6-2015	Regulatory Guidelines for Centers performing Bioavailability and Bioequivalence Studies	01
Guide line	July-2023	Egyptian Guidelines For Conducting Bioequivalence Studies for Marketing Authorization of Generic Products	03

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	Aug-2024	Guidelines For Human Pharmaceuticals Variations	05

guideline For Registration Of Human pharmaceutical products

Type	Issue date	description	Issue No.
Guide line	OCT-2022	Good Review Practice Guideline
Guide line	Mar-2023	Egyptian Guidelines on CTD Quality Module For Human Pharmaceuticals	02
Guide line	Mar-2023	Guidelines on Assessment of safety & efficacy that impact withdrawal, suspension or revocation of registration procedures or marketing authorization license-	02
Guide line	April-2023	Guidelines on Emergency Use Approval	04
Guide line	April-2023	Guidelines on the Rules and Procedures of Listing Active Pharmaceutical Ingredients (APIs) for Medicinal Product	01
Guide line	Dec-2023	Guideline On Dossier Requirements of Human Pharmaceutical Products for Registration and Re-registration	04
Guide line	Aug-2024	Guidelines on Reliance Practices During Registration of Medicinal Products	04
Guide line	Oct-2024	Regulatory Guideline on Organizing the Rules and Procedures of the Reregistration of Human pharmaceutical Products in Accordance with the EDA Chairman Decree No. (150) of 2022	06
Guide line	Dec-2024	Regulatory Guideline on Organizing the Rules and Procedures of Registration of Human Pharmaceutical Products in Accordance with the Different Cases Based on Egyptian Drug Authority Chairman Decree No. (450)	04
Guide line	Mar-2025	Regulatory Guide on The Registration of Synthetic Peptides Human Pharmaceutical Products that refer to a Reference Peptide Product of rDNA Origin	03
Guide line	Apr-2025	Egyptian Guidelines on Quality Module for Human Pharmaceuticals products submitted for Re-registration	01

Regulatory Guidelines for the General Administration For Veterinary products registration

Type	Issue date	description	Issue No.
دليل تنظيمي	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
دليل تنظيمي	02/2024	Guideline on Veterinary Pharmaceuticals Variations	01
دليل تنظيمي	03/2024	Guideline of Registering Veterinary Pharmaceuticals Imported from Reference Countries According to the Fast Track Registration System	03
دليل تنظيمي	10/2024	Guidelines on Naming of Veterinary Pharmaceuticals	05

Regulatory Guidelines for the General Administration For Herbal Medicinal products registration

Type	Issue date	description	Issue No.
دليل تنظيمي	Aug-21	Egyptian Guidelines for Registration of Herbal Medicines	02
دليل تنظيمي	Sep-21	Executive Procedures of Reviewing the Cards of Herbal Medicine Products	01
دليل تنظيمي	Sep-21	Executive Procedures of Reviewing the Names of Herbal Medicine Products	01
دليل تنظيمي	Sep-22	Executive Procedures of the Decree of Egyptian Drug Authority's President No. (572) of 2022 on Regulating Procedures of Registration/Re-registration of the Complementary Medical Products	01
دليل تنظيمي	Oct-22	Executive Procedures for Regulating Registration/Re-registration Procedures for Herbal Pharmaceutical Products acc. to Decision of Technical Committee for Drug Control at 23/01/2020	03

Regulatory Guidelines for the General Administration For Cosmetic products registration

Type	Issue date	description	Issue No.
دليل تنظيمي	6-Mar-22	Regulatory Guide for Cosmetics Notification	01
دليل تنظيمي	Apr-2025	Claims Guide for Cosmetics Notification	05

Regulatory Guidelines for the General Administration For Antiseptics and Biocides products registration

Type	Issue date	description	Issue No.
دليل تنظيمي	Feb-2025	Regulatory and Guidance Guideline and Business Rules for Antiseptics/Disinfectants Registration	03
دليل تنظيمي	Feb-2025	Regulatory Guidelines and Work Rules for the Registration of Pesticides	03

Regulatory Guidelines