WHEREAS, it is necessary to ensure the
safety, quality, efficacy of active
pharmaceutical ingredient and input during
their importation, storage, distribution,
transportation, and handling;
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 ...
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 ...
Clinical research is necessary to establish the relative safety and effectiveness of specific health
and pharmaceutical products and healthcare practices. Much of what is known today about the risk
and benefits of specific ...
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;
it is necessary to protect public
health through the regulation of Medicine
Manufacturers engaged in the processing of
active and inactive ingredients for further
processing and distribution of medicines
manufactured ...
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 ...
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 ...
The following definitions are provided to facilitate understanding of the Guideline; they apply
only to the words and phrases used in this Guideline. Although every effort has been made to use
standard definitions, the ...
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 ...
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, ...
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 ...
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 ...
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 ...
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 the safety, efficacy and quality as well as rational use of medicines. Article 19 (1) of
the proclamation decrees that ...
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 ...
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 ...
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, ...