Gaps in Veterinary Pharmaceuticals and Pesticide Regulation: GMP Compliance, Postmarket Surveillance, and Institutional Reforms

Background: In Ethiopia, veterinary pharmaceuticals and agricultural pesticides are vital to maintaining agricultural productivity and food security, yet their quality and safety regulation face significant challenges. Objectives: This study aimed to assess the regulatory framework, institutional capacity, and routine quality assurance practices related to veterinary drugs and agricultural pesticides in Ethiopia. Problems in routine practices and common product defects were assessed. Methods: Retrospective analysis of regulatory practice records (2017–2022), cross-sectional stakeholder surveys, and focal regulatory expert discussions were employed to collect data. Data sources included were institutional postmarket surveillance and foreign good manufacturing practice (GMP) visit records, routine pesticide registration, and market authorization practices. Descriptive statistics are used to summarize findings on data collection and analysis. Results: The GMP inspection records (N = 79) revealed the experience of 20 major and 8 critical deficiencies, with 4.2% and 8.5% of observed deficiencies leading to company and production line rejections from market entry. Postmarket surveillance records reveal that 8.2% of veterinary drug samples fail to comply with required standards. Additionally, the observation for regulatory processes and practices showed inconsistencies in the use of reference standards and the absence of specific guidelines for regulatory decisions. Furthermore, the study revealed that the pesticide regulatory system lacked codified procedures and quality control infrastructure. Conclusion: The study found that the country’s veterinary pharmaceutical and pesticide regulatory system exhibits critical weaknesses in GMP compliance, postmarket surveillance, and institutional coherences, contributing to the circulation of substandard products and environmental health risks. The study suggests that urgent reforms are required, including harmonized quality standards, investment in laboratory infrastructure, digital regulatory tools, strengthened interagency coordination, and stabilization of institutional mandates to align with international benchmarks and protect public health.