Assessment of veterinary drugs regulatory framework in Ethiopia
| dc.contributor.advisor | Dr. Gebretekle, Gebremedhin B(PhD) | |
| dc.contributor.advisor | Marew, Tesfa(MS. Pharm) | |
| dc.contributor.author | Zeru, Hailu | |
| dc.date.accessioned | 2020-12-01T12:05:58Z | |
| dc.date.accessioned | 2023-11-06T08:09:06Z | |
| dc.date.available | 2020-12-01T12:05:58Z | |
| dc.date.available | 2023-11-06T08:09:06Z | |
| dc.date.issued | 2020-08 | |
| dc.description.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. | en_US |
| dc.identifier.uri | http://etd.aau.edu.et/handle/123456789/23791 | |
| dc.language.iso | en_US | en_US |
| dc.publisher | Addis Abeba University | en_US |
| dc.subject | Ethiopia, products, regulation, regulatory authority, veterinary drugs | en_US |
| dc.title | Assessment of veterinary drugs regulatory framework in Ethiopia | en_US |
| dc.type | Thesis | en_US |