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.
- Identify regulatory challenges in initiating TB clinical trials and drug/regimen approvals.
- Foster dialogue among key regulatory agencies, the WHO, and NTPs to develop strategies to mitigate these regulatory challenges.
- Identify more efficient regulatory pathways to facilitate TB drug/regimen reviews.
4Q, 2015 Progress:
The GRP-WG planned satellite session for the upcoming Union Conference…
- The planned GRP-WG satellite session for the upcoming Union Conference was cancelled due to a conflicting meeting of the New Partnership for Africa’s Development (NEPAD) in Ethiopia (December, 2015)
- Vincent Ahonkhai (Gates Foundation) presented at the NEPAD meeting on behalf of the GRP-WG to the primarily health authority audience. Presentation introduced CPTR and the efforts of GRP-WG to highlight collaborative review procedures that could be applied to TB drug/regimen assessment, potentially expediting these processes in high burden-TB countries.
- Positive presentation feedback and interest in additional information on these collaborative procedures led by the WHO has spurred the GRP-WG to plan a follow-up meeting on this topic.
- Outlined session for April, 2016 workshop to highlight progress with WHO’s pilot efforts for collaborative review procedures, including perspectives from WHO, regulatory authorities, and sponsor.
- Feedback from GRP-WG members on wanting to engage more and connect with Regulatory Science Consortium.