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.

The Local Production & Assistance Unit (LPA) assists governments to conduct holistic situational analyses with a tool to identify gaps in key areas for promoting sustainable and quality local production, such as policy coherence, the business environment, regulations and quality assurance, infrastructure, and the market landscape of the national industry. Several approaches for the analysis are used, including situational assessments, benchmarking and roadmap development and implementation. Evidence-base recommendations are proposed and enable governments to take a targeted approach, prioritize needs-based technical support and manage expectations in promoting local production.
Situational Assessment
phase II: report of a case study in four sub-Saharan countries
A literature review and critical analysis