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A framework to support new product introduction in national health systems
Resource Library
CHAI ARV Approvals Database
Last Updated: January 2025 A Stringent Regulatory Authority (SRA) is a medicines regulatory authority that enforces and ensures medicines...
Jan 13
198
Regulatory Filing Overview - US FDA, WHO, GF ERP, and EMA
This presentation provides an overview of the regulatory filing process via globally recognized agencies for reviewing drug, in vitro...
Jan 1, 2021
64
Global Fund Sourcing and Management of Health Products
The Global Fund provides regular updates on ARVs found to be quality assured, including updates on quality assurance issues and changes...
Jun 3, 2019
11
WHO Prequalification Product List
The WHO Prequalification of Medicines Programme (WHO PQ) helps ensure that medicines supplied by procurement agencies meet acceptable...
Jun 3, 2019
250
US FDA Approved and Tentatively Approved ARVs
This President's Emergency Plan for AIDS Relief (PEPFAR) Database, hosted on the US Food and Drug Administration (US FDA) website,...
Jan 7, 2019
56
NDRA Registration Waiver Process
National drug regulatory authorities (NDRAs) are mandated to ensure that all medicines and medical devices used in country are safe,...
Aug 26, 2017
18
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