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 products and treatments has come from randomized controlled clinical
trials that are designed to answer important scientific and health care questions. However, early
1960, there were widespread concern about the safety and control of investigational drugs and the
clinical research process developed among members of medical profession, scientific community,
regulatory authorities, and the public. This concern and subsequent international meeting serves a
base for the development of Good Clinical Practice (GCP) at an international level, later developed
by International Council for Harmonization (ICH).
According to article 4, sub article 11 of the Food, Medicine and Healthcare Administration and
Control Proclamation No. 661/2009, a national executive authority is responsible to authorize the
conduct of clinical trials, monitor the process as to its conduct in accordance with good medical
procedure as well as GCP, evaluate the results and authorize the use of or to publish the results in
such a way that it benefits the public; or suspend or otherwise withdraw approval for the conduct
of a clinical trial where necessary. Article 15 of this Proclamation provides further detail on the
requirements for clinical trials.
To implement the Proclamation No. 661/2009, Ethiopian Food, Medicines and Healthcare
Administration and Control Authority was established by Council of Ministers Regulation No.
189/2010. Similarly, articles 22, 24 – 28 of Food, Medicine and Healthcare Administration and
Control Council of Ministers Regulation No. 299/2013 provides a detailed description of
responsibilities and activities of the Authority, investigators and/or sponsors.
This Guideline supersedes the previous guideline developed based on the Proclamation No.
176/99. The previous guideline was unable to answer the current scientific developments. Hence,
this requires the need for revision of this Guideline.
Accordingly, all clinical trials carried out in the territory of the Federal Democratic Republic of
Ethiopia must be reviewed by the Authority for use of the investigational product or intervention
in human subjects and to ensure that the research is appropriately designed to meet its stated
objectives as stated in the Proclamation No.661/2009 and Regulation No. 299/201