Despite considerable progress, the Pan American Health Organization (PAHO) estimates that 30% of the population of the Americas still do not have access to the health care they need because of multifaceted barriers. On April 9, leaders, including Mexico’s President Andrés Manuel López Obrador, PAHO director Carissa Etienne, and UN High Commissioner for Human Rights Michelle Bachelet, gathered with academics, activists, and representatives of social movements in Mexico City to hear the report of the Commission on Universal Health in the 21st Century (…) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30864-5/fulltext
The GBT Revision VI replaces all tools previously used by WHO, representing the first truly ‘global’ tool for benchmarking regulatory systems. The GBT is designed to evaluate the overarching regulatory framework and the component regulatory functions (e.g. clinical trial oversight) through a series of sub-indicators that may also be grouped and examined according to nine cross-cutting categories or themes, for example, quality and risk management system. Fact sheets have been developed for each sub-indicator to guide the benchmarking team and ensure consistency in the evaluation, documentation and rating of the sub-indicator.
The GBT also incorporates the concept of ‘maturity level’ or ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 ( existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement). Revision VI of the GBT is comparable to Revision V while at the same time incorporating refinements intended to improve its usability.
WHO intends to use Revision VI of the GBT to evaluate and publicly designate WHO-listed authorities (WLAs) that have been objectively documented to perform at ML 3 or ML 4*. The proposed definition for WLAs and process by which this designation or ‘listing’ would occur will be the subject of a concept note that will be made available for public consultation in early 2019.
GBT Revision VI was developed to benchmark the regulatory systems for medicines and vaccines, but with a view to incorporating other product types in the future. Future revisions are expected to address blood products (including whole blood, blood components and plasma-derived medicinal products) and medical devices, including diagnostics. Beta versions of these tools have been developed and are expected to be finalized in 2019.
For more information go to https://www.who.int/medicines/regulation/benchmarking_tool/en/