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Aim <p>Most low- and middle-income countries have weak regulatory systems that compromise public health and hinder access to medicines that are quality-assured, safe, effective, and affordable. This issue is partly due to inadequate competency-based training for medicine regulators. This study evaluated the feasibility and effectiveness of using the World Health Organization’s (WHO) Global Competency Framework for Regulators (GCF) to design and evaluate clinical assessor training for regulatory staff from African National Regulatory Authorities (NRAs).</p> Subject and methods <p>The GCF was used to develop the German GHPP PharmTrain fellowship programme for African clinical assessors. It guided the creation of candidate profiles, participant selection, and programme evaluation. Eleven participants from Ghana, Tanzania, and Zimbabwe were chosen based on competencies identified by the GCF. Data were collected through surveys and tests administered before, immediately after, and six months following the training.</p> Results <p>Participants demonstrated significant improvement in GCF-derived competencies, particularly in role-specific competencies (RSC) and clinical and regulatory knowledge. The average RSC score increased from 5.7 to 7.3 (on a 0–10 scale), with high agreement between self-assessments and supervisor evaluations (average discrepancy &lt; 1.06). Correct responses in regulatory and clinical knowledge tests improved from 52.6% to 73.2%.</p> Conclusions <p>The GCF effectively aided trainee selection and performance assessments. It supports training evaluations tailored to practical work contexts, helping to identify needs, customize content, and measure progress. Alongside the WHO Global Benchmarking Tool, the GCF could be pivotal in enhancing NRA performance by enabling systematic evaluation of individual competencies and aligning training with regulatory needs.</p>

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The ‘WHO Global Competency Framework for Regulators of Medicines’ as an evaluation tool for training programmes

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年6月5日

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  • Tobias Siefen,
  • Hanna Flamme,
  • Luther Gwaza,
  • Regine Lehnert

摘要

Aim

Most low- and middle-income countries have weak regulatory systems that compromise public health and hinder access to medicines that are quality-assured, safe, effective, and affordable. This issue is partly due to inadequate competency-based training for medicine regulators. This study evaluated the feasibility and effectiveness of using the World Health Organization’s (WHO) Global Competency Framework for Regulators (GCF) to design and evaluate clinical assessor training for regulatory staff from African National Regulatory Authorities (NRAs).

Subject and methods

The GCF was used to develop the German GHPP PharmTrain fellowship programme for African clinical assessors. It guided the creation of candidate profiles, participant selection, and programme evaluation. Eleven participants from Ghana, Tanzania, and Zimbabwe were chosen based on competencies identified by the GCF. Data were collected through surveys and tests administered before, immediately after, and six months following the training.

Results

Participants demonstrated significant improvement in GCF-derived competencies, particularly in role-specific competencies (RSC) and clinical and regulatory knowledge. The average RSC score increased from 5.7 to 7.3 (on a 0–10 scale), with high agreement between self-assessments and supervisor evaluations (average discrepancy < 1.06). Correct responses in regulatory and clinical knowledge tests improved from 52.6% to 73.2%.

Conclusions

The GCF effectively aided trainee selection and performance assessments. It supports training evaluations tailored to practical work contexts, helping to identify needs, customize content, and measure progress. Alongside the WHO Global Benchmarking Tool, the GCF could be pivotal in enhancing NRA performance by enabling systematic evaluation of individual competencies and aligning training with regulatory needs.