Browsing General reference materials 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 ...
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 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 (1018)

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 ...
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 ...
የመድኃኒት እና የህክምና መሳሪያ አስመጪ፣ ላኪ እና ጅምላ አከፋፋይ ድርጅቶች ቁጥጥር መመሪያ ቁጥር 872/2014

Ethiopian Food and Drug Authority (2014)
የመድኃኒት ጎጂ ባህሪያት ክትትል ሥርዓት መመሪያ ቁጥር 932/2015 (Pharmacological Directive No. 932/2022)

Ethiopian Food and Drug Authority (2022)

መድኃኒት ጎጂ ባህርይ ክትትል ስርዓት የተመለከተ ዝርዝር የማስፈጸሚያ ስርዓት ባለመኖሩ በሃገሪቷ ውስጥ ጥቅም ላይ በሚውሉ መድኃኒቶች ላይ የጠቃሚነት እና የጎጂነት ምዘና ምርመራ ሂደት ሊይ ክፍተት በመፈጠሩ
የምግብ ጨው ቁጥጥር መመሪያ 361/2013

Ethiopian Food and Drug Authority (2012)

ለምግብነት እንዲሁም ለምግብ ማምረቻ ፋብሪካዎች የሚቀርብ ጨው በሀገራዊ ደረጃው ላይ የተቀመጠውን የጥራት ደረጃ እና የአዮዲን ይዘት ጠብቆ መድረሱን ለማረጋገጥ፤
የባህል መድኃኒት ምርት የብቃት ማረጋገጫ የምስክር ወረቀት እና የገበያ ፈቃድ አሰጣጥ መመርያ

Ethiopian Food and Drug Authority (2015)

የባህል መድኃኒት ምርቶች ጥራት፣ ደህንነት እና ፈዋሽነት ማረጋገጥ እና የህዝብን ጤና ማጎልበት አስፈላጊ በመሆኑ፤
የኮሮና ቫይረስ ግብአት አምራች፣ አስመጪና አከፋፋይ ድርጅት የብቃት ማረጋገጫ የምስክር ወረቀት አሰጣጥ ጊዜያዊ መመርያ

Ethiopian Food and Drug Authority (2012-01)

የኮሮና ቫይረስ በአለም አቀፍና በሀገረ ደረጃ እየተሰራጨ ያለና በአለም አቀፍ ጤና ተቋም በወረርሽኝ ደረጃ የተፈረጀ መሆኑ የሚታወቅ ሲሆን ይህ በሽታ ህብረተሰቡ ላይ የበለጠ አደጋ ከማድረሱ በፊት አስቀድሞ መከላከል አስፈለጊ ሆኖ በመገኘቱ፤
የጤና ተቋም አገልግሎት ማስታወቂያ መመሪያ

Ethiopian Food and Drug Authority (2006)

እያደገ ከመጣው የጤና ተቋም አገልግሎት ጋር በተያያዘ የማስተዋወቅ ተግባር በማናቸውም መንገድ የሚተላለፍበት ሁኔታ ደረጃውን ባልጠበቀ የጤና አገልግሎት እንዲሁም ሙያዊ ስነ ምግባርን ባላከበረ ማስተዋወቅ ምክንያት ሊደርስ የሚችለውን የጤና ችግር መግታት አስፈላጊ በመሆኑ፤

Browsing General reference materials by Author "Ethiopian Food and Drug Authority"

Browsing General reference materials by Author "Ethiopian Food and Drug Authority"

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