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 ...
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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 the safety, efficacy and quality as well as rational use of medicines. Article 19 (1) of
the proclamation decrees that ...
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 ...
WHEREAS, it is necessary to protect patient
by regulating medical gas manufacturer to
ensure that the safety, quality and
effectiveness of medical gas are maintained;
WHEREAS, it is necessary to ensure the
safety, quality, efficacy of active
pharmaceutical ingredient and input during
their importation, storage, distribution,
transportation, and handling;