http://repository.iphce.org/xmlui/handle/123456789/5308 2026-05-20T18:20:24Z http://repository.iphce.org/xmlui/handle/123456789/5373 Pharmaceutical products traceability master data guideline, 2nd edition Ethiopian Food and Drug Authority; 2022-01-01T00:00:00Z http://repository.iphce.org/xmlui/handle/123456789/5370 Trends in antimicrobial consumption in Ethiopia: A surveillance report 2020-2022 Ethiopian Food and Drug Authority Background: Antimicrobial resistance (AMR) poses a severe global health threat, driven by the overuse and misuse of antimicrobials across the human, agricultural, and veterinary sectors. To combat this, global and national AMR prevention and containment strategies have been implemented, necessitating continuous monitoring of antimicrobial consumption (AMC) as an integral part of antimicrobial stewardship interventions. 2022-01-01T00:00:00Z http://repository.iphce.org/xmlui/handle/123456789/5368 Risk-based guideline for post-marketing quality surveillance of medicines in Ethiopia Ethiopian Food and Drug Authority Surveillance activities that occur following market approval of a medicine, including: maintenance of product authorization and/or registration of variations or renewals; regular inspections of manufacturers, wholesalers, distributors, and retailers; quality control testing; pharmacovigilance; promotion control; public reporting of poor-quality products; handling of market complaints; and removal and disposal of non-compliant products. Post- marketing surveillance is typically considered a key regulatory function and refers to the set of comprehensive quality surveillance activities. 2024-01-01T00:00:00Z http://repository.iphce.org/xmlui/handle/123456789/5364 Risk-based guideline for post-marketing quality surveillance of medicines in Ethiopia Ethiopian Food and Drug Authority Good quality medicines are essential for efficient disease management. Substandard and falsified medicines can cause treatment failure and adverse reactions, increase morbidity and mortality, and contribute to the development of drug resistance. Vulnerable populations and patients with comorbidities are at particular risk of being harmed from receiving substandard or falsified medicines. Poor-quality medicines also increase health care costs to both patients and the health system as a whole, wasting resources that could otherwise be used to benefit public health. 2020-01-01T00:00:00Z