Medicine Registration in Ethiopia
Comprehensive support for pharmaceutical product registration with EFDA, ensuring compliance and efficient market entry.
Overview
Medicine registration in Ethiopia is regulated by the Ethiopian Food and Drug Authority (EFDA), which ensures that all pharmaceutical products meet quality, safety, and efficacy standards before they can be marketed in the country.
YAM BUSINESS provides end-to-end support for pharmaceutical companies seeking to register their products in Ethiopia, leveraging our deep understanding of EFDA requirements and local regulatory landscape.
Our team of experts, including former EFDA inspectors, guides you through every step of the registration process, from initial assessment to final approval, ensuring a smooth and efficient pathway to market.
Registration Process
Our streamlined approach to medicine registration in Ethiopia ensures efficient processing while maintaining full compliance with EFDA requirements.
Initial Assessment
Evaluation of product documentation and registration strategy
- Document review and gap analysis
- Registration pathway determination
- Timeline and strategy planning
Dossier Preparation
Compilation and preparation of all required documentation
- Administrative document preparation
- Technical document compilation
- Translation of documents (if required)
- Quality control and verification
EFDA Submission
Official submission to Ethiopian Food and Drug Authority
- Application submission
- Fee payment
- Receipt of acknowledgment
Review Process
EFDA evaluation and response to queries
- Response to EFDA queries
- Submission of additional information (if required)
- Follow-up on application status
Approval & Registration
Receipt of registration certificate and post-approval activities
- Receipt of registration certificate
- Import permit application
- Post-registration compliance planning
Required Documentation
Comprehensive documentation is essential for successful medicine registration in Ethiopia. YAM BUSINESS helps you prepare and organize all required documents according to EFDA standards.
- Application Letter
Formal request for product registration addressed to EFDA
- Authorization Letter
Letter authorizing local agent to act on behalf of manufacturer
- Certificate of Pharmaceutical Product (CPP)
WHO-format certificate from country of origin's regulatory authority
- GMP Certificate
Valid Good Manufacturing Practice certificate for manufacturing facility
- Business License
Copy of local agent's valid business license
- Registration Fee Receipt
Proof of payment of applicable registration fees
- Product Dossier
Comprehensive technical information about the product in CTD format
- Stability Studies
Long-term and accelerated stability data according to ICH guidelines
- Bioequivalence Studies
For generic products, comparing to reference product
- Method Validation Reports
Validation of analytical methods used for quality control
- Product Samples
Commercial samples for laboratory analysis and visual inspection
- Package Insert & Labeling
Proposed packaging materials, labels, and patient information leaflet
Important Note
All documents must be submitted in English or Amharic. Documents in other languages must be accompanied by certified translations. YAM BUSINESS provides translation services for technical documents to ensure accuracy and compliance with EFDA requirements.
Frequently Asked Questions
Common questions about medicine registration in Ethiopia and how YAM BUSINESS can help.
Our Global Clients
Trusted by pharmaceutical companies across multiple countries for EFDA compliance and Ethiopian market entry.
Our customers
JODAS EXPOIM PVT. LTD
PHARMAX INDIA PVT. LTD
Intellective Biologics (Suzhou) Co., Ltd
Skymap Pharmaceuticals Pvt. Ltd
HOF Pharmaceuticals Ltd
RENATA LIMITED
Advanov Pharma
Sovereign Pharma
Nobel İlaç (Nobel Pharmaceuticals)
EVA PHARMA
JODAS EXPOIM PVT. LTD
PHARMAX INDIA PVT. LTD
Intellective Biologics (Suzhou) Co., Ltd
Skymap Pharmaceuticals Pvt. Ltd
HOF Pharmaceuticals Ltd
RENATA LIMITED
Advanov Pharma
Sovereign Pharma
Nobel İlaç (Nobel Pharmaceuticals)