General reference materials: Recent submissions

  • 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 ...
  • Guideline to conduct good pharmacovigilance practice inspection 
    Ethiopian Food and Drug Authority (2025)
    The Ethiopian Food and Drug Authority (EFDA) is committed to safeguarding public health by ensuring the safety, efficacy, and quality of medicines circulating in the Ethiopian market. In alignment with its legal mandate ...
  • 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 the registration of plasma derived medical products 
    Ethiopian Food and Drug Authority (2025)
    The Ethiopian Food and Drug Authority (EFDA), under Proclamation 1112/2019, regulates all medicinal products, including plasma-derived biological products. Article 30(3) of the proclamation mandates that blood and blood ...
  • 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. ...
  • Guideline for risk management process for regulatory systems 
    Ethiopian Food and Drug Authority (2025)
    Strong regulatory services help ensure product safety, stabilize Authority processes, and protect consumers without compromising economic development or trade. This includes banning or restricting harmful products, ...
  • Guideline for remote GMP inspection 
    Ethiopian Food and Drug Authority (2025)
    The Ethiopian Food and Drug Authority (EFDA) is a national regulatory body established by the Proclamation No 1263/2021, and its mandatesare defined in the Regulation No 531/2023. One of its key responsibilities is to ...
  • Guideline for registration of monoclonal antibodies and related products 
    Ethiopian Food and Drug Authority (2025)
    The Ethiopia Food and Drug Authority (EFDA) is responsible for ensuring the safety, efficacy, and quality of medicines in Ethiopia, as mandated by the Food and Medicine Administration Proclamation No. 1112/2019. Article ...
  • 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 ...
  • Guidelines for quality agreement in pharmaceutical contract manufacturing 
    Ethiopian Food and Drug Authority (2025)
    For the purposes of this guideline, the following terms have the meanings hereby assigned to them. They may have different meanings in other contexts. Bulk Product means any medicine that has undergone all processing ...
  • Guideline for medicine and medicine raw material port clearance 
    Ethiopian Food and Drug Authority (2025)
    Ethiopia, similar to numerous developing nations, heavily depends on the importation of medicines and medical products. Although local pharmaceutical manufacturers are expanding their capabilities, it is essential for ...
  • Guideline for good clinical practice inspection, version 002 
    Ethiopian Food and Drug Authority (2025)
    Good Clinical Practice (GCP) Inspection refers to a systematic and independent examination of clinical trial process and documentation to ensure compliance with GCP guidelines and regulatory requirements. Its purpose is ...
  • Guideline for good clinical practice, version 004 
    Ethiopian Food and Drug Authority (2025-06)
    Good Clinical Practice is an international ethical and scientific standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. Clinical trials conducted in ...
  • Guideline for emergency use authorization of vaccines and therapeutics for Marburg Virus Disease 
    Ethiopian Food and Drug Authority (2025-11)
    Marburg virus disease (MVD) is a severe hemorrhagic fever with case fatality rates that can exceed 80%. The disease is caused by Marburg virus (MARV), a filovirus closely related to Ebola virus. Outbreaks are rare but ...
  • Guideline for drug information services 
    Ethiopian Food and Drug Authority (Dec 2025)
    Reliable, timely, and evidence-based drug information (DI) is vital to patient safety, rational medicine use, and regulatory decision-making. In Ethiopia, gaps in access to high-quality DI Services (DIS) contribute to ...
  • 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 clinical trial authorization 
    Ethiopian Food and Drug Authority (June 2025)
    To align with QMS document control SOP formatting; to align the timeline for non-routine application review and further review for non-routine; to incorporate an evaluation timeline for safety report and CT application ...
  • Guideline for medicinal product information 
    Ethiopian Food and Drug Authority (December 2)
    Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, ...
  • 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 ...
  • Good practice guideline for blood establishments, version 001 
    Ethiopian Food and Drug Authority (Jan 2026)
    Blood and blood component transfusion is a critical intervention in modern healthcare, often essential for saving lives, particularly in vulnerable populations such as children, women of childbearing age, and patients ...

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