loading page

Needs driven talent and competency development for the next generation of regulatory scientists in Africa
  • +8
  • Boitumelo Semete-Makokotlela,
  • Gugu Mahlangu,
  • David Mukanga,
  • Delese Darko,
  • Peter Stonier,
  • Luther Gwaza,
  • Portia Nkambule,
  • Precious Matsoso,
  • Regine Lehnert,
  • B Rosenkranz,
  • Goonaseelan Pillai
Boitumelo Semete-Makokotlela
South African Health Products Regulatory Authority

Corresponding Author:boitumelo.semete@sahpra.org.za

Author Profile
Gugu Mahlangu
Medicines Control Authority of Zimbabwe
Author Profile
David Mukanga
Bill & Melinda Gates Foundation
Author Profile
Delese Darko
Food and Drug Authority Ghana
Author Profile
Peter Stonier
King's College London Faculty of Life Sciences and Medicine
Author Profile
Luther Gwaza
World Health Organization
Author Profile
Portia Nkambule
South African Health Products Regulatory Authority
Author Profile
Precious Matsoso
Health Regulatory Science Platform
Author Profile
Regine Lehnert
Federal Institute for Drugs and Medical Devices
Author Profile
B Rosenkranz
Stellenbosch University Department of Medicine
Author Profile
Goonaseelan Pillai
CP Plus Associates
Author Profile


There is a critical skills gap on the African continent in regulatory sciences, and an acknowledged need to develop a long-term strategy for training and professional development of African regulatory personnel. Capacity building programs 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 gap and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.
23 Feb 2021Submitted to British Journal of Clinical Pharmacology
23 Feb 2021Submission Checks Completed
23 Feb 2021Assigned to Editor
25 Feb 2021Reviewer(s) Assigned
29 Mar 2021Review(s) Completed, Editorial Evaluation Pending
06 Apr 2021Editorial Decision: Revise Major
18 May 20211st Revision Received
19 May 2021Submission Checks Completed
19 May 2021Assigned to Editor
19 May 2021Review(s) Completed, Editorial Evaluation Pending
26 May 2021Reviewer(s) Assigned
09 Jul 2021Editorial Decision: Accept
Feb 2022Published in British Journal of Clinical Pharmacology volume 88 issue 2 on pages 579-586. 10.1111/bcp.15020