The 10-page guide provides an introduction to the role medical regulatory authorities play in access to tuberculosis (TB) medicines.
Created by the US HIV activist organisation the Treatment Action Group, the document begins by broadly outing regulators roles before covering issues like pre-approval access to TB drugs as well as accompanying concerns regarding equitable access. These concerns are illustrated with country examples.
The guide then moves on to explain how TB drugs move from research into clinical trials and also cases of accelerated access to drugs like bedaquiline and delamanid.
Finally, the guide outlines strategies activists can use to increase access to new TB drugs such as import waivers, off-label use and operational research.
Download the guide: An Activist’s Guide to Regulatory Issues