TB is one of the major health problems in many countries. In order to treat the disease, countries must ensure that FDC and other anti-TB drugs are of proven safety, efficacy and quality, and are available and affordable. In many countries, the time taken to assess and ensure the safety, efficacy and quality of drugs is unnecessarily long, thus affecting the timely availability of these badly needed drugs. While ensuring safety, efficacy and quality of the drugs is critical, timely availability of the drugs is equally important from a public health perspective. Therefore, drug regulatory authorities must design mechanisms to facilitate timely availability of drugs, whilst not compromising the safety and quality of the drugs. A fast-track system is needed. Where possible and appropriate, DRAs should follow existing registration practices.