ArticlePLOS global public health2023
Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers.
Article in PLOS global public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- MPOX outbreak in Africa: the urgent need for local manufacturing of the vaccine and decolonized health systems.BMC public health · 2025Pooled it
- New approach methodologies for next-generation risk assessment of nanomaterials and nano-enabled products.Nano convergence · 2026Review
- Moving beyond a legacy paradigm: A vision for equitable access to quality medicines in Africa.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Mapping Biomedical Engineering Education and Research in Sub-Saharan Africa: A Bibliometric and Systematic Analysis.Advances in medical education and practice · 2026Review
- Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making-Report from the 4th ISoP Africa Chapter Meeting.Drug safety · 2026Article
- The World Health Organization Coalition of Interested Parties Network: a unified and coordinated approach to regulatory system strengthening.Frontiers in medicine · 2026Article
- Strengthening pharmacovigilance and regulatory capacity in Southern Africa (SPaRCS): achievements, experiences and lessons learned from a participatory action learning project.Frontiers in drug safety and regulation · 2026Article
- Cancer immunotherapy clinical trials to support urgently needed access in low- and middle-income countries: a report from the SITC global access and impact committee.Journal for immunotherapy of cancer · 2025Review
- Mitigating inequitable access to appropriate antibiotics in low- and middle-income countries.JAC-antimicrobial resistance · 2025Review
- From Command-Control to Lifecycle Regulation: Balancing Innovation and Safety in China's Pharmaceutical Legislation.Healthcare (Basel, Switzerland) · 2025Article
- Bridging the gap: enhancing blood regulatory functions in African contexts through comparative analysis.Frontiers in medicine · 2025Article
- Understanding the regulatory-procurement interface for medicines in Africa via publicly available information on standards, implementation, and enforcement in five countries.Journal of pharmaceutical policy and practice · 2025Article
- Comparison of the review models and regulatory timelines of seven countries participating in the ECOWAS-MRH initiative: identifying opportunities for improvement.Frontiers in medicine · 2025Article
- Performance analysis of EAC joint GMP inspections (2016-2022): a pathway to strengthening regulatory systems and building capacity in Africa's less resourced authorities.Frontiers in medicine · 2025Article
- Regulatory reforms will boost African vaccine production and access.Nature medicine · 2024Article
- Quality improvement in medicines regulation: a retrospective analysis of the Pharmacy Board of Sierra Leone before and during quality management system implementation.BMC health services research · 2024Article
- WHO-listed authorities (WLA) framework: transparent evidence-based approach for promoting regulatory reliance towards increased access to quality-assured medical products.Frontiers in medicine · 2024Article
- Ethiopian Pharmaceutical Sector Stakeholder Perspectives on Regulatory Harmonization in IGAD: A Descriptive Study.Inquiry : a journal of medical care organization, provision and financingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
In the African Medicines Regulatory Harmonization initiative, national regulatory authorities (NRAs) within each of Africa's regional economic communities coordinate their activities, rely on the work of one another and other trusted regulatory authorities, and apply other principles of smart regulation. The first regional medicines regulatory harmonization (MRH) initiative in Africa was launched in 2012, with the goal of accelerating access to quality, safe, effective medical products, and now five MRH initiatives are active on the continent. Thus, a wealth of knowledge regarding best practices and approaches to dealing with common challenges has accumulated. The goal of this qualitative study was to gather and share information on these best practices. To do this, we conducted interviews with key participants from four regional MRH initiatives-the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD)-as well as representatives from the pharmaceutical industry. Here we explore major themes that emerged from the interviews: 1. Transparency and reliability are critical; 2. Reliance is essential for smart regulation; 3. Multiple successful strategies for NRA capacity building have been identified; 4. Communication between heads of agencies is essential; 5. Cooperation at the regional level is not possible without leadership at the NRA level; 6. Sustainable funding remains challenging; and 7. Industry has important insights. We hope that the information on best practices shared in this article can benefit regional MRH initiatives inside and outside of Africa, ultimately helping them accelerate access to quality, safe, effective medical products.
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.