Ethiopian Pharmaceutical Sector Stakeholder Perspectives on Regulatory Harmonization in IGAD: A Descriptive Study

Flawed regulatory oversights restrict access to quality-assured medicines. Not more than 16% of African regulatory authorities have the capacity to execute standard regulatory functions; the challenges seem more pronounced in the Intergovernmental Authority on Development (IGAD) member states. Regional harmonization initiatives elsewhere demonstrated promising outcomes. However, progress in the IGAD Medicines Regulatory Harmonization Program has stalled calling for renewed commitment. This study explored the perspectives of pharmaceutical sector stakeholders in Ethiopia, and international experiences regarding the implementation of harmonized framework in the IGAD region. A survey-based descriptive design was sent to 582 professionals from key pharmaceutical sectors. Data analysis and reliability tests were conducted using SPSS version 26. An in-depth document review was carried out to inform the proposal of a harmonized regional framework. A total of 477 (82.0%) participants completed the survey. A large majority (83%) concurred the feasibility of regional harmonization and identified key benefits such as improved technical capacity for expedited regulatory services, enhanced access to quality medicines, and improved collaboration. Nevertheless, participants highlighted potential barriers such as instabilities, regulatory systems heterogeneity, and financial constraints. Benchmarking global and continental experiences, a centralized regulatory procedure comprising 6 milestones with an average target authorization timeline of 330 days along with phased prerequisite steps, is proposed as a feasible framework for IGAD. Participants largely favored the adoption of a harmonized regional regulatory framework similar to those implemented elsewhere in Africa. The success of IGAD's harmonization efforts would be strengthened by establishing regional office with legal framework to ensure balanced contributions and benefits among member states, facilitating judicious listing of priority products, and coordinating phased implementation.