IPHC-E Repository System

Browsing Ministry of Health-Ethiopia by Author "Ethiopian Food and Drug Authority"

Browsing Ministry of Health-Ethiopia by Author "Ethiopian Food and Drug Authority"

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  • Adverse drug events reported on DTG-containing regimens: Preliminary analysis report 
    Ethiopian Food and Drug Authority (2021-10)
    Although antiretroviral therapy (ART) has changed the natural history of HIV infection, the presences of adverse events have limited its efficacy. Almost all ARV drugs have some adverse effects which can be specific to ...
  • Adverse event following immunization (AEFI) surveillance course for health professionals: Facilitator’s guide 
    Ethiopian Food and Drug Authority (2022-08)
    concerted global and national efforts have been exerted to stop the spread of COVID19 and address the human and economic impacts of COVID19 on the society. It is widely understood that COVID19 has posed considerable ...
  • COVID-19 vaccines safety surveillance guideline 
    Ethiopian Food and Drug Authority (2021-09)
    On 30 January 2020, World Health Organization (WHO) declared the outbreak due to a novel coronavirus, severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), also known as COVID-19, as a public health emergency ...
  • Emergency medicine list 
    Ethiopian Food and Drug Authority (2022-07)
    Pharmacotherapy has always been an integral part of health care system and will remain so in the future. It relies on the availability of safe, effective and affordable medicines with the required quality, quantity. ...
  • Food and Health Products Regulatory Sector Transformation Plan II 
    Ethiopian Food and Drug Authority (2021-02)
    Ethiopia is engaged in a rapid and comprehensive development schemes to transition from poverty to sustainable and reliable growth and prosperity. The Government has therefore invested heavily in health system strengthening ...
  • Good review practices (GRevPs) guideline 
    Ethiopian Food and Drug Authority (2020-06)
    The Ethiopian Food and Drug Authority (EFDA) is striving and exerting efforts to become a strong and resilient regulatory authority so as to safeguard the health of the Ethiopian population from health risks associated ...
  • Guideline for decommissioning and disposal of medical devices 
    Ethiopian Food and Drug Authority (2022)
    Medical devices are essential components of the health care system and are crucial in the prevention, diagnosis, and treatment of disease and in rehabilitation. However, medical devices that no longer meet specifications ...
  • Guideline for preparation and publication of public assessment reports for approved medicines 
    Ethiopian Food and Drug Authority (2022-09)
    As part of the commitment to transparency, the Ethiopian Food and Drug Authority (EFDA) publishes information relating to the evaluation of applications via public assessment reports, hereinafter ‘Ethiopian Food and Drug ...
  • Guideline for registration of antiseptics and disinfectants 
    Ethiopian Food and Drug Authority (2021-03)
    The Ethiopian Food and Drug Authority (EFDA) is mandated by the proclamation No. 1112/2019 to register and undertake related regulatory assessment of antiseptics & disinfectants. Article 19(1) of the proclamation decrees ...
  • Guideline on medical products special import permit 
    Ethiopian Food and Drug Authority (2023-05)
    Medical products cannot be treated in the same way as ordinary commodities. Their manufacture and subsequent handling within the distribution chain must conform to prescribed standards and be rigorously controlled. ...
  • Guidelines for registration of biotherapeutic protein products prepared by recombinant DNA technology 
    Ethiopian Food and Drug Authority (2018)
    Ethiopia has been made huge strides to improve access to safe, quality and efficacious medicines to the public. The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is responsible to ensure ...
  • Guidelines for registration of similar biotherapeutic products (SBPs) 
    Ethiopian Food and Drug Authority (2018)
    Ethiopia has been made huge strides to improve access to safe, quality and efficacious medicines to the public. The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is responsible to ensure ...
  • Guidelines for software as medical device and artificial intelligence based medical device 
    Ethiopian Food and Drug Authority (2022-09)
    The Food and Medicine Administration Proclamation (FMA) 1112/2019 mandates the Food and Drug Authority of Ethiopia (EFDA) to assess the safety, performance and quality of medical devices and give authorization for ...
  • List of essential medicines for Ethiopia 
    Ethiopian Food and Drug Authority (2010)
    In most cases, healthcare services are provided both by the private and the public sectors. However, provision of basic health services usually remains to be the responsibility of the public sector. This relies, among ...
  • List of medicines for community pharmacy 
    Ethiopian Food and Drug Authority (2021-10)
    Pharmacotherapy has always been an integral part of the healthcare system and will remain so in the future. This relies on the availability of safe, effective, quality and affordable medicines. Besides, this depends ...
  • List of medicines for health centers 
    Ethiopian Food and Drug Authority (2012)
    It is by far known that medicines are integral components of a health care system. Although there are immense active pharmaceutical entities in the global market, limiting medicines that shall be used within a given ...
  • Pfizer COVID-19 vaccine safety monitoring and surveillance in Ethiopia 
    Ethiopian Food and Drug Authority (2022)
    Adverse Events Following Immunizations (AEFIs) are reported to Ethiopian Food and Drug Authority (EFDA) by health care providers and vaccine recipients. EFDA investigates and assesses all AEFI reports and conducts causality ...
  • Pharmacovigilance training for healthcare professionals: Trainer’s guide 
    Ethiopian Food and Drug Authority (2022-04)
    Ethiopian Food and Drug Authority (EFDA) is the national regulatory authority vested by law to control medicines and food that aim to improve the quality, safety, and efficacy of medicines and food to ensure the safety ...
  • Regulatory preparedness and mitigation strategy for emergency health threats 
    Ethiopian Food and Drug Authority (2020-08)
    From the past and current experiences, emergency public health threats including coronavirus (COVID-19) are spreading with alarming rate which affects the stability of the global medical products supply chains. For the ...
  • Risk management plan guideline for COVID-19 vaccines 
    Ethiopian Food and Drug Authority (2021)
    Ethiopia has successfully managed to lead a well-coordinated response plan including vaccination of COVID-19 vaccines to stop the spread of COVID-19 and address the human and economic impacts on the society. The Ethiopian ...

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