Evidence map›Paper›PMID 38660423›Full record

ArticleFrontiers in medicine2024

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.

Claudia P Alfonso, Guy B N'Jambong, Alaa Magdy, Laura Di Trapani, Rutendo Kuwana, Abraham G Kahsay, Diadié Maïga, Sybil N A Ossei-Agyeman-Yeboah, Aimé B Djitafo Fah, Margareth Ndomondo-Sigonda

Abstract read
In one paragraph

Article in Frontiers in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

10 authors.

Claudia P AlfonsoRegulatory Systems Strengthening, World Health Organization, Geneva, Switzerland.
Guy B N'JambongEssential Drug and Medicines, World Health Organization, Dakar, Senegal.
Alaa MagdyRegulatory Systems Strengthening, World Health Organization, Geneva, Switzerland.
Laura Di TrapaniRegulatory Systems Strengthening, World Health Organization, Geneva, Switzerland.
Rutendo KuwanaIncident and Substandard and Falsified, World Health Organization, Geneva, Switzerland.
Abraham G KahsayRegulatory Convergence and Networks, World Health Organization, Geneva, Switzerland.
Diadié MaïgaRegulatory Systems Strengthening, World Health Organization, Geneva, Switzerland.
Sybil N A Ossei-Agyeman-YeboahWest Africa Health Organization, Bobo-Dioulasso, Burkina Faso.
Aimé B Djitafo FahSub-Regional Program for the Harmonization of National Pharmaceutical Policies in Central Africa, Coordination Organization for the Fight Against Endemic Diseases in Central Africa, Yaoundé, Cameroon.
Margareth Ndomondo-SigondaAfrican Medicines Regulatory Harmonization Initiative, African Union NEPAD Agency, Pretoria, South Africa.

Funding

World Health Organization 001
6 · The paper itself

Abstract

Background: Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency. Aims: This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally. Objectives: The study used NRA self-assessment outcomes to identify common gaps in four critical regulatory pillars and estimate the cost of addressing them from regional perspectives that aimed at raising the maturity level of regulatory institutions. Methods: A cross-sectional study, using the WHO Global Benchmarking Tool (GBT), was conducted between 2020 and 2021 with five NRAs from ECCAS and ECOWAS member states that use French and Spanish as Results: The 10 NRAs operated in a non-formal-to-reactive approach (ML1-2), which hinders their ability to ensure the quality of MPHT and respond appropriately to public health emergencies. Common gaps were identified in four critical regulatory pillars-good regulatory practices, preparedness for public health emergencies, quality management systems, and substandard and falsified medical products-with overall cost to address gaps estimated at US$3.3 million. Contribution: We elaborated a reproducible method to strengthen regulatory systems at a regional level to improve equitable access to assured-quality MPHT. Our bottom-up approach could be utilized by RECs to address common gaps through common efforts.

Indexed as

common regulatory needsgood regulatory practiceinstitutional development plannational regulatory authoritiespublic health emergenciesquality management systemsregulatory systems strengtheningsubstandard and falsified medical products

Identifiers

PMID38660423
PMCPMC11042247

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.