Critical pathway for new tb diagnostics
Asia
​Cross-region Analysis
In Asia, the critical pathways for introducing new TB diagnostics vary significantly across countries, shaped by each nation’s unique healthcare systems, regulatory frameworks, and implementation needs. To provide a structured comparison, we have compiled and tabulated the key steps involved in each country. The indicators used for comparison are grouped into thematic areas, as outlined here. Each theme includes a set of sub-questions tailored to capture country-specific nuances.
​
Access the Cross-Regional Analysis here
​
Africa
​Cross-region Analysis
In Africa, the Critical Path Analysis (CPA) of new TB diagnostics explores regulatory and market entry processes across the continent. It highlights key challenges, including limited ratification of the African Medicines Agency (AMA) treaty and capacity constraints, as well as opportunities such as leveraging regulatory harmonization through AMA, the African Medicines Regulatory Harmonization (AMRH) initiative, and Africa CDC to accelerate approvals and foster local innovation. The CPA emphasizes the need for multi-stakeholder collaboration, regulatory alignment, and public-private engagement to expand access to quality TB diagnostics and close the diagnostic gap in Africa.
Access the Cross-Regional Analysis here​
​