Adapting the WHO Global Competency Framework for Regulators of Medicines: Implementation lessons from the South African Health Products Regulatory Authority

AIMS: Medicines regulatory authorities require skilled staff to ensure timely, consistent and high-quality regulatory decision making. The World Health Organization Global Competency Framework (WHO-GCF) for Regulators of Medicines provides a common reference for defining regulatory workforce competencies while allowing adaptation to local needs. We describe the South African Health Products Regulatory Authority's (SAHPRA) implementation of the WHO-GCF and lessons learnt for other national regulatory authorities. METHODS: SAHPRA adapted the WHO-GCF through consultations with internal regulatory assessors, their supervisors and external experts. Activities, skills, responsibilities and competencies were reviewed for relevance and usability and adapted to reflect SAHPRA functions. The three WHO-GCF proficiency levels were expanded to four, informing revised assessor job profiles. The framework was implemented in a secure digital platform for self-assessment, supervisor validation and development planning. Graphical and summary reports were used to develop training and development plans at the team and individual levels. Hypothetical scenarios illustrate potential applications while protecting SAHPRA data confidentiality. RESULTS: The adapted framework retained the WHO-GCF domains relevant to SAHPRA with approximately 20% fewer competency statements. The laboratory analyst role was omitted, and SAHPRA-specific emphases such as biosimilar evaluation were added. Implementation challenges included assessment length, role specificity and the need to supplement ratings with evidence such as work samples. CONCLUSIONS: The WHO-GCF can be operationalized as an institution-specific framework while retaining a shared regulatory competency language. Local adaptation, involvement of frontline staff and evidence of competence are important for implementation. Competency frameworks can support targeted capacity building, reliance and work-sharing.