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Browsing Ethiopian Food and Drug Authority (EFDA) by Issue Date

Browsing Ethiopian Food and Drug Authority (EFDA) by Issue Date

Now showing items 1-20 of 59

Risk-based guideline for post-marketing quality surveillance of medicines in Ethiopia

Ethiopian Food and Drug Authority (2020)

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 ...
Guidelines for WHO pre-qualified medicines through collaborative registration procedure

Ethiopian Food and Drug Authority (2020)

Marketing authorization (MA) of pharmaceutical products is one of the crucial regulatory requirements to ensure safety, quality and efficacy of medicines. The Ethiopian Food and Drug Authority has categorized finished ...
Guideline for registration of low-risk medicines

Ethiopian Food and Drug Authority (2020)

The Ethiopian Food and Drug Authority (EFDA) is mandated by the Proclamation No. 1112/2019 to ensure safety, efficacy and quality as well as rational use of medicines. Article 19 sub-article 1 of the proclamation decrees ...
Pharmaceutical products barcoding guideline

Ethiopian Food and Drug Authority (2021)

The Ethiopian pharmaceutical supply chain system faces many challenges including substandard and falsified products, ineffective system for product recalls, medication errors and supply chain inefficiencies. Furthermore, ...
Trends in antimicrobial consumption in Ethiopia: A surveillance report 2020-2022

Ethiopian Food and Drug Authority (2022)

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 ...
Pharmaceutical products traceability master data guideline, version 002

Ethiopian Food and Drug Authority (2022)

Ethiopia has made great strides to improve access to safe, quality and efficacious pharmaceutical products to the public. The EFDA is responsible for ensuring the safety, quality and efficacy of pharmaceutical ...
Pharmaceutical products traceability master data guideline, 2nd edition

Ethiopian Food and Drug Authority; (EFDA, 2022-01)
iLicenese user manual: A practical guide on how to use eRIS- iLicense to manage licensing activities for the Ethiopian Food and Drug Authority

Ethiopian Food and Drug Authority (2023)

This document is a manual designed to provide a step-by-step guide on how to use the iLicense application. iLicense is a web-based tool that allows importers, exporters, wholesalers, and manufacturers to apply for a ...
Report on cohort event monitoring (CEM) of Dolutegravir containing ART regimens in selected health facilities of Addis Ababa, Ethiopia

Ethiopian Food and Drug Authority (2023)

Even though the introduction of DTG based ART has provided a potent treatment option for persons living with HIV, there is growing evidence from clinical settings that use of DTG can result in hyperglycemia, serious ...
Adverse drug reactions related to drug-resistant tuberculosis (DR-TB) treatment in Ethiopia: Active tuberculosis drug-safety monitoring and management

Ethiopian Food and Drug Authority (2023)

As part of the global recommendation, the national TB program and Ethiopian Food and Drug Authority have set active TB-drugs safety monitoring and management (aDSM) as an essential requirement during the introduction of ...
Single-dose oral bioequivalence study of Primaquine 15 mg tablet (test product) and Primaquine 15 mg tablet (reference product) in healthy adult human subjects under fasting conditions

Ethiopian Food and Drug Authority (2024)

WHO prequalification offers the possibility of a line extension based on demonstrating proportionality with the adult 15 mg tablet. For a generic manufacturer, a bioequivalence study must be performed comparing the generic ...
Risk-based guideline for post-marketing quality surveillance of medicines in Ethiopia

Ethiopian Food and Drug Authority (2024)

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, ...
Effectiveness of an integrated program for the prevention of rheumatic heart disease in endemic regions: an incomplete stepped wedge cluster randomized trial

Ethiopian Food and Drug Authority (2024)

Timely detection and treatment of Group A beta-hemolytic streptococcal infections (GAHBS) pharyngitis among children represents an effective target for primary prevention of Rheumatic heart disease (RHD). To study different ...
A revised Tafenoquine dose to improve radical cure for Vivax malaria -Tafenoquine dosing revised

Ethiopian Food and Drug Authority (2024)

Tafenoquine (TQ), as a single dose regimen, has significant advantages over the longer courses of primaquine (PQ) needed to achieve radical cure of P. vivax. The current data available show that the recommended fixed ...
Guideline for consumer reporting of adverse event of medicines

Ethiopian Food and Drug Authority (2024)

a consumer in healthcare is anyone; patient or client or family; who uses, has used, or may use any health or health related service. It is not limited to those currently using a service. Consumer report: is a report of ...
Guideline for registration of radiopharmaceuticals

Ethiopian Food and Drug Authority (2024)

Radiopharmaceuticals are defined as “medicines which have one or more radionuclide substances combined with pharmaceutical agents (cold kits) used in the diagnosis and treatment of human diseases. However, some radionuclides ...
Guideline for temporary market authorization of medicinal gasses

Ethiopian Food and Drug Authority (2024)

Medicinal gases play a critical role in modern healthcare, serving as essential therapeutic agents for various medical conditions. They comprise of medicinal products / drugs that are supplied as a gas or gas mixtures. ...
Feasibility, safety and efficacy of concomitant curcumin in patients undergoing palliative radiotherapy for FIGO stage IIIB–IVA cervical cancer: An open-label pilot trial

Ethiopian Food and Drug Authority (2024)

The rationale for combining curcumin with radiotherapy in the context of treating stage IIIB-IVA cervical cancer aims to enhance therapeutic efficacy while mitigating treatment related toxicities. Envisaged synergies ...
Assessing new paediatric tablets of primaquine as radical cure in Ethiopia.

Ethiopian Food and Drug Authority (2024)

Drug formulations that children are able to use and comfortable to take type has been overlooked for many years. The availability of pediatric drugs in the right doses, taste and odour/flavour is critically important. ...
Guideline for registration of oral care and skin care products with therapeutic claims

Ethiopian Food and Drug Authority (2024)

The Ethiopian Food and Drug Authority (EFDA) is mandated by the proclamation No.1112/2019 to ensure the safety, efficacy and quality as well as rational use of medicines. Article 19 (1) of the proclamation decrees that ...

Browsing Ethiopian Food and Drug Authority (EFDA) by Issue Date

Browsing Ethiopian Food and Drug Authority (EFDA) by Issue Date

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