Policy Implementation Package for new TB drug introduction WHO, 2016

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The landscape of drug development for treatment of tuberculosis (TB) has evolved dramatically over the past 10 years. Newly developed and re-purposed drugs are being investigated in clinical trials, and novel drugs have been approved by stringent regulatory authorities under accelerated or conditional procedures. Promising novel regimens are being tested for the treatment of drug-susceptible and drug-resistant TB, and regimen development will likely accelerate with the introduction of new TB drugs into the market.

Reaching populations in need rapidly and equitably when a new drug or drug regimen has demonstrated evidence-based benefits is a priority for WHO. In its new End TB Strategy with targets to end the Global TB Epidemic by 2035, WHO advocates for rapid uptake of new drugs and associated research to optimize implementation and impact.

To address challenges in preparing and enabling safe and effective uptake of new drugs or regimens under programmatic conditions, WHO has developed a Policy Implementation Package (PIP).

The goal of the PIP is to support countries in preparing for introduction of new TB drugs and/or regimens, based on WHO policy guidance, in order to better serve patients and communities in need.

The PIP provides the key elements of a roadmap for introduction of new TB drugs and/or regimens and aims to complement existing and new policy guidance on the use of new drugs for the treatment of TB or MDR-TB. There are six elements in this package:

  1. Minimum requirements for country preparedness and planning.
  2. National Implementation plan for introduction of new TB drugs and/or regimens.
  3. Monitoring and evaluation of new drugs and regimens, including pharmacovigilance and drug resistance surveillance.
  4. Private sector engagement.
  5. Systems approach for ensuring uninterrupted supply of quality-assured drugs.
  6. Operational research.

This package provides briefing notes on steps to be considered in addressing each of these elements, and accompanying checklist and background documentation. Further implementation guidance will be provided through model national implementation plans, which build on these notes.