Back to search

Article

Operationalisation of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure – timelines to recommendation and national registration decisions

2026-04-24

Abstract excerpt

<h4>Background</h4> Regulatory inconsistency across African countries contributes to duplicative scientific assessments, prolonged approval timelines, and delayed access to essential medical products. To inform the operationalisation of the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) programme implemented Africa’s first continental pilot study for the scientific evaluatio...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work
62cd5920-beb0-56e3-873c-b690a772c361
DOI
10.64898/2026.04.22.26351547
Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest
Interactive article relationship graphSelect a related publication card to move it into the centre and load its closest explainable connections. Solid lines are source-backed structured connections. Dashed lines are semantic discovery signals and are not scientific evidence.
Operationalisation of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure – timelines to recommendation and national registration decisionsDOI 10.64898/2026.04.22.26351547
Conformance of Patient Information Leaflet of Selected Innovator and Generic Medicinal Products to Regulatory Requirements in EthiopiaSemantic proximity
The Role of Intellectual Property Rights on Access to Medicines in the WHO African Region: 25 Years After the TRIPS AgreementSemantic proximity
Trends in the Utilization of Medicines Sold in the Private Sector Post- Registration in South Africa and the Implications for Similar CountriesSemantic proximity
Ensuring Quality Medicine: A Comprehensive Overview of EMA and DGDA's History, Structure, and Functions.Semantic proximity
Developing Standards and Practice Guidelines for Pharmaceutical Services in Ghana: A review of Structure, Process and OutcomeSemantic proximity
Deficiency Patterns in FDA Complete Response Letters for New Drug and Biologics Applications: A Cross-Sectional AnalysisSemantic proximity
Post-trial access practices in conducted clinical trials for Malaria, Tuberculosis, and Neglected Tropical Diseases (NTDs) across Sub-Saharan African countries: A quantitative studySemantic proximity
Improving data use for decision making by neglected tropical disease program teams: eight use casesSemantic proximity
Initiatives to Promote Access to Medicines After the Publication of National Policy on Comprehensive Care of People With Rare Diseases in BrazilSemantic proximity
Academic challenges on ATMPs’ development: a regulatory perspectiveSemantic proximity
Real World Evidence – Current Developments and PerspectivesSemantic proximity
Time to Patients’ Access to New Medicines in Greece: Evaluation of Health Technology Assessment (HTA) Process from July 2018 until January 2021.Semantic proximity
Select a neighboring publication to make it the new centre.