Medicines Market Authorization Strategy 2017

Ethiopia has been putting tremendous efforts in implementing the National Medicine Policy (1993)
and Health Sector Development Programme (HSDP) since the last two decades. During this period,
our country has made huge strides to improve access to safe, quality and efficacious medicines to the
public. The political commitment and good leadership, community mobilization with the concept of
community ownership and strengthening collaboration & partnership has remarkably improved the
health system in Ethiopia.
Currently, the government of Ethiopia has committed to improve quality and equity of the health
services. This is expressed through the national Growth and Transformation Plan II (2015/16-
2019/20), National Strategy and Plan of action for Pharmaceutical Manufacturing Development in
Ethiopia (2015-2025) and National Health Sector Transformation Plan (2015/16-2019/20).
Recognizing this, the Authority has developed Health Regulatory Sector Transformation Plan,
HRSTP (2015/16-2019/20) and actively implementing regulatory activities and initiatives to ensure
that medicine regulations are streamlined, effective and efficient. These strategies and plans aim to
assist pharmaceutical companies and create conducive environment for the growth of the
pharmaceutical industry and scaling up of medicine export.
Despite the impressive progresses made, the Authority still confronted with new and increasingly
complex challenges. The infiltration of illegal medicines to the market, unprecedented shortages of
critical medicines, limited number of approved quality medicines and long waiting time for
registration are some of the challenges. The medicines dossier assessment, cGMP inspection and
quality testing procedures did not keep pace with the increasing demand of the pharmaceutical
industries for marketing authorization and the public need for quality and safe medicines. To
overcome those challenges, the Authority has set a strategy having options to expedite medicine
market authorization. This strategy builds upon previous successes and challenges, and the current
global experiences.
In the strategy, we have set transformation procedures for medicines dossier assessment, cGMP
inspection, quality testing, and communication and collaboration procedures. I believe that
successful implementation of this strategy will help us to achieve the demands of our people to
access safe, quality and effective medicines. Hence, I call up on health professionals, civil societies,
pharmaceutical organizations, development partners and all stakeholders to put a coordinated effort
to realize these strategies.