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 ...
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, ...
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 ...
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, ...
WHEREAS, to ensure production, import, export,
storage, distribution, transport, prescribing, dispensing,
and use of narcotic and psychotropic medicine is
carried out in accordance with the law;
After assessing all existing opportunities, the TF finally decided to adopt or recognize one of the existing
nomenclatures based on predetermined criteria. Following a series of workshops that used nomenclature
selection ...
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 ...
WHEREAS, in order to produce and supply
for sale traditional medicinal products that
have been used for health purposes by the
local people for many years, it is necessary
to ensure their safety, quality and efficacy
with ...
WHEREAS, it is necessary to protect public health
through regulation of low-risk medical device
manufacturers to operate in accordance with safety,
quality and effectiveness requirements of the
products;
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 ...
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 ...
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 ...
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. ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...