Assessment of veterinary drugs regulatory framework in Ethiopia
No Thumbnail Available
Date
2020-08
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Abeba University
Abstract
Strong regulatory framework enables to ensure that the manufacture, trade and use of veterinary
drugs are effectively regulated, and to protect and promote animal health, animal production and
public health at large. To perform core regulatory functions efficiently, the regulatory bodies
require having adequate legislations and regulatory tools, appropriate organizational structure,
adequately trained human resources, sustainable finance, and effective cooperation between
different regulatory bodies and with other law enforcing bodies. This study therefore aimed to
assess veterinary drugs regulatory framework in Ethiopia. An archival review and expert panel
based qualitative study was conducted from April to September 2019. A detailed review of
legislations, regulatory activity plans and reports, and human and financial resource archives was
conducted. Forty experts, 33 of them working in veterinary drug regulatory authority and seven
from private veterinary drug traders, were grouped in to six groups for a panel discussion.
Experts were allowed to dialogue on each semi-structured questions until they reach consensus.
Narrative description of the experts’ consensus and linking them with the archival review
findings were conducted to report findings. This study revealed that the federal regulatory body
had adequate human and financial resources. However, the federal regulatory body was poorly
structured and regions have neither their own legislations nor regulatory bodies. Unavailability
of guidelines for registration of traditional medicines, post-marketing surveillance and good
manufacturing practice procedure, poor regulation of government owned entities and poor
communication of regulatory activities to the public were also shortcomings of the regulatory
system. Generally, limited regulatory legislations and tools and poor organizational structures
were identified as the major gaps of the regulatory framework. Therefore, development and
adoption of the lacking legislations and tools as well as re-structuring of the federal regulatory
body and establishment of regional regulatory bodies should be done to strengthen the regulatory
framework.
Description
Keywords
Ethiopia, products, regulation, regulatory authority, veterinary drugs