Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

Global Competency Framework

The Global Competency Framework for Regulators of Medicines (GCF) provides a framework for best practices and general considerations aimed at harmonizing workforce development efforts for the regulation of medicines by establishing an internationally accepted set of organizational and role-specific competencies.

The GCF provides recommendations for the competency requirements for regulators across the identified regulatory functions and maturity levels, as defined by the Global Benchmarking Tool (GBT) that is used to guide countries through gap analysis and systematic institutional development.  The maturity model in the GBT represents a tool for a National Regulatory Authority’s (NRA) development and a continuum of the NRA's capabilities in performing regulatory functions.  Thus, the GCF allows competency modelling by individual NRAs across the maturity levels, particularly maturity levels 1 to 3, aligning individual capabilities with the organizational strategy and business processes. 

Global competency framework for regulators of medicines
The Global Competency Framework for Regulators of Medicines (GCF) provides a framework for best practices and general considerations aimed at harmonizing...