| Minimum requirements for country preparedness and planning | A set of basic health and programmatic capacities must be in place at the country level for the optimal introduction and implementation of a new TB drug or drug regimen according to WHO policy recommendations |
| Development of an implementation plan for introduction of new TB drugs or regimens | This national implementation plan must take into account the various operational models for introduction of new TB drugs or regimens, depending on the TB epidemics situation and level of preparedness in a country, and the type of drug or regimen of drugs to be introduced |
| Monitoring and evaluation of new drugs and regimens, including pharmacovigilance and drug resistance surveillance | Introduction of new TB drugs or regimens requires careful monitoring of safety (particularly if drugs are being introduced following phase IIb trials), based on active pharmacovigilance, and of drug resistance. |
| Private sector engagement | Introduction of new TB drugs requires a set of best practice regulations from the local ministry of health to provide rational access and protection of new drugs, particularly in the context of substantial involvement of the private sector in TB care |
| Systems approach for ensuring uninterrupted supply of new and existing quality-assured medicines | This describes the need for a clearly established procurement and supply chain management system at country level |
| Operational research | Can assist in the implementation and scale-up processes and help support evaluation of public health impact, through the collection of relevant information to measure feasibility, cost-effectiveness, acceptability and impact of the new drugs or regimens |