| Developing New Treatments | |
Regulatory Engagement |
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Regulatory Engagement
The twenty-first century has seen a dramatic upsurge in TB drug development — movement due, in part, to the TB Alliance and its partners. But few TB drugs have been approved in forty years, and regulatory guidelines specific to TB drug development are lacking.
Under standard drug development circumstances, regulatory authorities such as the Food and Drug Administration (FDA) in the United States, and the European Medicines Agency (EMEA), have established procedures that provide a clear path toward the registration of new treatments. No such guidelines exist for novel TB drugs. Equally problematic, no such guidelines exist for testing new drug treatments in combination for TB.
The TB Alliance is engaging regulatory authorities — the FDA, the EMEA, and regulatory authorities in endemic countries such as South Africa and Brazil — in concrete discussions, to develop new guidelines for TB drug registration and approval. We are defining country-specific registration requirements, and building a coalition of partners to advocate for regulatory harmonization. The TB Alliance is also working with regulatory authorities on a project-specific basis. These project meetings, though confidential, allow the TB Alliance and its partners to address key issues for lead programs like PA-824 and moxifloxacin.
The TB Alliance is further catalyzing the creation of TB drug-specific regulatory guidelines through a series of Open Forums, intended to identify and address crucial issues involved in advancing new TB treatments to registration, and ultimately to the patient. These meetings bring together regulators, TB drug developers, and other interested stakeholders (such as academics, TB care providers, public health policy-makers, and community advocates). The Open Forums are designed to encourage participation by representatives of regulatory agencies and National TB Control Programs from both major industrialized and high burden countries. These meetings also highlight key questions related to the development of novel combination therapies.
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