Mechanism to guide procurement of diagnostics not yet in receipt of stringent regulatory approval

Overview

Diagnostics for the prevention, diagnosis or management of AIDS, TB or malaria are procured with international donor funds and in significant quantities for use in low- and middle-income countries. The Global Fund to fight AIDS, Tuberculosis and Malaria (the Global Fund) and UNITAID each operates a quality assurance policy to guide such procurement. This stipulates that procured diagnostics must be quality assured: for example, they have undergone stringent assessment by a regulatory authority. But quality-assured diagnostics are not always available. In their absence, treatment may be delayed or not administered at all. Modelling itself on the Expert Review Panel for medicines (ERP),1 the recently piloted Expert Review Panel for Diagnostics (ERPD) aims to provide guidance to procurers who find themselves in this situation.