Evidence map›Paper›PMID 34346098›Full record

ReviewBritish journal of clinical pharmacology2022

Needs-driven talent and competency development for the next generation of regulatory scientists in Africa.

Boitumelo Semete-Makokotlela, Gugu N Mahlangu, David Mukanga, Delese Mimi Darko, Peter Stonier, Luther Gwaza, Portia Nkambule, Precious Matsoso, Regine Lehnert, Bernd Rosenkranz and 1 more

Open access · hybridAbstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.7field-weighted citation impact, top 7% of its field
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

14 citing papers in PubMed, 26 citations in OpenAlex.

  1. Review
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  3. Bioequivalence centres in Africa: current state and opportunities for growth.Journal of pharmaceutical policy and practice · 2025
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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

11 authors at 10 institutions in 7 countries.

Boitumelo Semete-MakokotlelaSouth African Health Products Regulatory Authority, Pretoria, Gauteng, South Africa.ORCID 0000-0002-0491-4374
Gugu N MahlanguMedicines Control Authority of Zimbabwe, Harare, Zimbabwe.ORCID 0000-0002-3435-5577
David MukangaBill & Melinda Gates Foundation, Seattle, USA.
Delese Mimi DarkoFood and Drugs Authority, Accra, Ghana.
Peter StonierPharmaceutical Medicine Department, Institute of Pharmaceutical Sciences, Faculty of Health Sciences and Medicine, Kings College London, UK.
Luther GwazaWorld Health Organization, Geneva, Switzerland.ORCID 0000-0003-1880-1095
Portia NkambuleSouth African Health Products Regulatory Authority, Pretoria, Gauteng, South Africa.
Precious MatsosoDepartment of Pharmacy & Pharmacology, Faculty of Sciences, University of the Witwatersrand, South Africa.
Regine LehnertGHPP-PharmTrain project, Federal Institute for Drugs and Medical Devices (BfArM), Germany.
Bernd RosenkranzFundisa African Academy of Medicines Development, Cape Town, South Africa.ORCID 0000-0002-9867-8826
Goonaseelan Colin PillaiDivision of Clinical Pharmacology, University of Cape Town, South Africa.ORCID 0000-0002-5658-3837
South African Reserve Bank · ZAFederal Institute for Drugs and Medical Devices · DEFood and Drug Administration · THGates Foundation · USKing's College - North Carolina · USStellenbosch University · ZAUniversity of Cape Town · ZAUniversity of the Witwatersrand · ZAWorld Health Organization · CHZimbabwe National Water Authority · ZW

Funding

World Health Organization 001
6 · The paper itself

Abstract

Capacity building programmes for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever-expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients. Monitoring and evaluation of capacity development interventions will be essential to show value of investments and ultimately guide continued funding and sustainability. This paper reviews the skills and human capacity gaps, reports on regulatory assessment pathways used in Ghana, South Africa and Zimbabwe and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.

Indexed as

EcosystemPhysiciansCapacity BuildingHumansSouth AfricaAfricacapacity developmentcareerspublic healthregulatory sciences

Identifiers

PMID34346098
PMCPMC9291465
OpenAlexW3188567152

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.