Book traversal links for 4.2.2 Area 2 – Regulatory approval and importation of products
Step 2.1 – Complete national regulatory processes
For new technologies, the ministry of health should work closely with the relevant government authorities, manufacturers and authorized service providers to meet the requirements of the national regulatory authority. Sufficient time must be allowed for review of the application and any supplementary evidence. This is particularly applicable to the new TBST and IGRA consumables, because regulatory approval is generally provided for a specific test produced by a specific manufacturer, not for the class of the test. The regulatory pathway for approval of TBST will probably be the same as the one for TST materials. In many settings, because TB infection skin test material is injected, it is considered to be a medicine or a vaccine; therefore, the time to approval may be longer with greater requirements for data, especially for safety, and the procedures for regulatory approval need to be initiated well in advance. Regulatory approval of more than one test may improve access to tests and allow countries to choose between different tests based on test performance, as well as cost–effectiveness, feasibility and other operational aspects.
Step 2.2 – Determine importation requirements
National authorities should be consulted to determine relevant processes to be followed for importation of equipment and supplies for new tests. Countries should work closely with manufacturers and authorized service providers of equipment and consumables, to determine importation and registration requirements. Consumables for the TB infection tests (both IGRA and TBST) should be imported respecting manufacturers’ recommendations for transportation and storage. As discussed previously, TB infection skin tests avoid the need for equipment, except for refrigeration (cold chain). WHO-recommended new IGRAs use the same equipment as the previously approved QFT-GIT. Countries that were already using those tests will need to plan for scale-up, but regulatory and importation processes should already be in place.
Step 2.3 – Conduct country validation and verification studies, as required
Validation studies are an essential part of the WHO review process and development of recommendations for the use of a new test. Once large-scale validation studies have been published and a test’s target performance characteristics have been established, laboratories or field sites that are implementing the method do not need to repeat such large-scale studies. Small-scale verification studies to demonstrate that the laboratory can achieve the same performance characteristics obtained in the validation studies are sufficient. Countries must make their own determination on the need for verification, particularly of a new TBST.