- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines
- Mots-clés > EU Medicines Agencies Network
- Mots-clés > Good Regulatory Practice (GRP)
- Mots-clés > marketing authorization
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > registration - Collaborative Registration Procedure (CRP)
- Mots-clés > regulatory framework
- Mots-clés > regulatory harmonization
- Mots-clés > regulatory institutional capacity
(2019; 4 pages)
The human being is key in any chain of operations, including public health, but is also by nature the most flexible and variable impacting on predictability, consistency, transparency, and quality of decisions. Predictably, the low regulatory capacity in low- and middle- income countries (LIMC) is partly due to the lack of appropriately qualified, trained and experienced regulators to ensure access to quality, safe and efficacious medical products in those settings. The Institute of Medicine (IOM) report described the current mishmash of inconsistent training offered to LMICs as part of the problem. Consequently, systematic regulatory workforce development was identified as one of the critical areas to address the gaps in regulatory capacity for medical products in LMICs.
Although there is progress in harmonizing technical standards, joint activities, and information and work sharing, having an internationally accepted set of competencies will maximize the benefits of collaboration and cooperation in medical product regulation. While the World Health Organization (WHO) has established a well-recognized process for benchmarking and strengthening regulatory systems, there is a growing recognition that the current approach in regulatory capacity development must include a common global competency framework if the desired public health outcomes are to be achieved.
To this end, as part of the regulatory systems strengthening, WHO is working with partners to develop a global competency framework and global curricula to support training and professional development of regulatory staff. The focus of this paper is to highlight the progress on the development of the global competency framework, and the proposed competency framework for medical product regulation.