Pharmacovigilance Services in Ethiopia

Ethiopia's expanding pharmaceutical market underscores the need for a properly structured safety monitoring system and effective pharmaceutical surveillance (PV) processes. Companies need to establish robust procedures to monitor the safety of their medicines and evaluate the risk of new ones and ensure compliance with regulations throughout the lifespan of the product. Pharmacovigilance is the foundation to convert safety data into valuable information through providing an organized method of managing adverse events, risk assessment, benefit-risk analysis and ongoing postmarketing surveillance.

The DDReg has a wide range of pharmacovigilance and drug safety services for Ethiopia and works with Marketing Authorization Holders (MAHs) biotechnology firms, pharmaceutical manufacturers importers and distributors, as also health institutions to increase their capacities in ensuring security of the drugs.

DDReg offers a range of pharmacovigilance services in Ethiopia helping companies establish the right, efficient, and effective security systems for drugs that are aligned with local regulations and international pharmacovigilance standards.

• We help organizations evaluate and enhancing their pharmacovigilance system which include the development of processes and security governance and regulatory ready and aligning in line with Ethiopian Food and Drug Authority (EFDA) expectations.
• Adverse Drug Reaction Reporting and ICSR Management: DDReg oversees the whole cycle of safety cases including adverse events, intake of cases medical review, MedDRA codes, quality inspections following-up tasks, and assistance with regulatory reporting.
• Post-Marketing Safety Surveillance: We advocate constant monitoring of medicinal products by reviewing adverse events as well as safety data assessments and the proactive detection of the possibility of safety concerns.
• Safety Reporting and Benefit-Risk Assessment: Our experts provide the aggregate safety evaluations, benefit risk assessments and safety data analysis to aid organizations in maintaining continuous surveillance of safety for their products.
• Literature Monitoring and Signal Detection: We do a literature review and data analysis to detect emerging safety warning signs and to support proactive risk-management strategies.
• Pharmacovigilance Quality Systems and Documentation: DDReg helps in the development and maintaining of PV documentation, which includes SOPs, pharmacovigilance agreements CAPA support, quality systems audit preparation, and preparation for inspections.
• Local PV Support and Global System Integration: We help companies with the management of safety information and support for regulatory communications, and the integration of Ethiopian-specific pharmaceutical surveillance with international safety systems.
• Pharmacovigilance Outsourcing Services in Ethiopia: DDReg offers a variety of outsourcing options that allow organizations to outsource specific PV tasks or handle complete pharmacovigilance activities with the same level of the quality, efficiency and regulatory readiness.