EFDA Guidelines & Resources

Access the latest Ethiopian Food and Drug Authority guidelines, regulations, and compliance resources.

Official EFDA Resources

Updated 2024

Downloadable PDFs

Important Updates & Notices

Stay informed about the latest regulatory changes and important announcements from EFDA.

High Priority

January 2024

Updated GMP Requirements

New requirements for pharmaceutical manufacturing facilities effective March 2024.

Medium Priority

December 2023

Medical Device Classification Changes

Updated classification criteria for Class B and Class C medical devices.

Medium Priority

November 2023

Electronic Submission System

New online portal for regulatory submissions now available.

EFDA Guidelines by Category

Comprehensive collection of official EFDA guidelines organized by product category for easy access.

Pharmaceutical Guidelines

Comprehensive guidelines for pharmaceutical product registration and compliance

Medicine Registration Guideline

Complete guide for pharmaceutical product registration with EFDA

PDF

2.5 MB

Updated 2024

Good Manufacturing Practice (GMP) Guideline

WHO-GMP standards and requirements for pharmaceutical manufacturing

PDF

3.2 MB

Updated 2024

Bioequivalence Study Guideline

Requirements and procedures for bioequivalence studies

PDF

1.8 MB

Updated 2023

Stability Testing Guideline

Guidelines for stability testing of pharmaceutical products

PDF

2.1 MB

Updated 2023

Medical Device Guidelines

Guidelines for medical device registration and quality management

Medical Device Registration Guideline

Complete guide for medical device registration and classification

PDF

2.8 MB

Updated 2024

Medical Device Quality Management System

ISO 13485 requirements and implementation guidelines

PDF

2.3 MB

Updated 2023

Clinical Evaluation Guideline

Requirements for clinical evaluation of medical devices

PDF

1.9 MB

Updated 2023

Food & Cosmetic Guidelines

Guidelines for food products and cosmetic registration

Food Product Registration Guideline

Requirements for food product registration and labeling

PDF

2.0 MB

Updated 2024

Cosmetic Product Registration Guideline

Guidelines for cosmetic product safety and registration

PDF

1.7 MB

Updated 2023

Nutritional Supplement Guideline

Requirements for dietary supplements and nutraceuticals

PDF

1.5 MB

Updated 2023

Quick Access Resources

Frequently accessed forms, checklists, and reference materials for regulatory compliance.

Application Forms

Standard application forms for all product categories

Checklists

Document checklists for registration submissions

Fee Structure

Current fee schedule for all EFDA services

EFDA Portal

Direct access to official EFDA online portal

Frequently Asked Questions

Common questions about EFDA guidelines and regulatory compliance in Ethiopia.

Our Global Clients

Trusted by pharmaceutical companies across multiple countries for EFDA compliance and Ethiopian market entry.

Our customers

JODAS EXPOIM PVT. LTD

India

PHARMAX INDIA PVT. LTD

India

Intellective Biologics (Suzhou) Co., Ltd

China

Skymap Pharmaceuticals Pvt. Ltd

India

HOF Pharmaceuticals Ltd

India

RENATA LIMITED

Bangladesh

Advanov Pharma

India

Sovereign Pharma

India

Nobel İlaç (Nobel Pharmaceuticals)

Türkiye

EVA PHARMA

Egypt