ArticleInquiry : a journal of medical care organization, provision and financing
Ethiopian Pharmaceutical Sector Stakeholder Perspectives on Regulatory Harmonization in IGAD: A Descriptive Study.
Article in Inquiry : a journal of medical care organization, provision and financing. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.