Registration

CHAI ARV Approvals Database

Last Updated: January 2023 A Stringent Regulatory Authority (SRA) is a medicines regulatory authority that enforces and ensures medicines...

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...

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...

WHO Prequalification Product List

The WHO Prequalification of Medicines Programme (WHO PQ) helps ensure that medicines supplied by procurement agencies meet acceptable...

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,...

NDRA Registration Waiver Process

National drug regulatory authorities (NDRAs) are mandated to ensure that all medicines and medical devices used in country are safe,...

HIV New Product Introduction Toolkit