Table 2.

Regulatory barriers limiting MICs stakeholders from achieving better results to foster vaccine innovation and access.

REGULATORY BARRIER	SPECIFIC ISSUES
Regulatory limitations delay vaccine approval and access for MICs	Lack of stringent regulatory agencies in the Global South*, affects timing to review and approve vaccines, which vaccines countries have access to, availability of vaccines for exportation, and impacts the willingness of stakeholders to invest in R&D. In Latin America at least six countries (Argentina, Brazil, Chile, Colombia, Cuba and Mexico) with level 4 regulatory agencies, could be further strengthened to become a stringent supervisory body for the region Pooled procurement agencies^ may paradoxically limit exportation opportunities for new vaccines from MICs because of regulatory aspects and WHO prequalification process