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Global Regulatory Pathways Workgroup (GRP-WG) Q4-2015

The Global Regulatory Pathways Workgroup (GRP-WG) identifies efficiencies in the regulatory pathway to develop a novel regimen by fostering dialogue among key regulatory agencies, the WHO, and National Tuberculosis Programs (NTPs). This Workgroup develops pathways for regulatory approval that incentivize regimen development. Regulators from countries or regions with high TB burden are included in this process.

Because of the nature of TB, the CPTR’s goal is to foster development, testing, and regulatory review of a novel regimen(s) containing multiple compounds. Defining regulatory pathways is necessary to accelerate this process.

Objectives:                                            

4Q, 2015 Progress:

The GRP-WG planned satellite session for the upcoming Union Conference…

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