Evidence map›Paper›PMID 40573977›Full record

ArticleVaccines2025

Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products.

Alemayehu Duga, Nebiyu Dereje, Mosoka Papa Fallah, Tedi Angasa, Abebe Genetu Bayih, Edinam Agbenu, Ngashi Ngongo, Raji Tajudeen, Jean Kaseya

Abstract read
In one paragraph

Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. 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 · 2026
    Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Alemayehu DugaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.ORCID 0000-0003-3944-1025
Nebiyu DerejeAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.ORCID 0000-0001-5406-4171
Mosoka Papa FallahAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.
Tedi AngasaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.
Abebe Genetu BayihAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.
Edinam AgbenuIntercountry Support Team, Regional Office for Africa, World Health Organization, Ouagadougou 100701, Burkina Faso.ORCID 0009-0001-7056-8991
Ngashi NgongoAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.
Raji TajudeenAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.
Jean KaseyaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, Ethiopia.

Funding

Mastercard Foundation Not applicableWorld Health Organization 001
6 · The paper itself

Abstract

The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations-Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe-have attained ML3 status, marking a significant milestone in the continent's regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks.

Indexed as

counterfeit medicinesemergency preparednesslocal manufacturingpharmacovigilance systemregulatory maturitysafety and efficacy

Identifiers

PMID40573977
PMCPMC12197664

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.