Country and regional regulatory capacity strengthened

geography, etc.) when conducting knowledge-sharing activities among countries; supporting the aspects of preparedness for public health emergencies that relate to the regulation and supply of quality-assured and safe health products, including prequalification services; and safeguarding the uptake of new or innovative products in low- and middle-income countries by strengthening safety surveillance, including by ensuring that surveillance systems are in place to manage the risk of medicines, in particular the anticipated or unknown risks of new, complex medicines. The Secretariat will support countries to: implement regulation through reliance and national regulatory authorities networks; strengthen national regulatory capacity to ensure the quality of health products by assessing regulatory systems using the WHO global benchmarking tool as the standard to determine the maturity and performance of national regulatory authorities for designation as WHO-Listed Authorities; address identified gaps in regulatory capacity for quality-assured and safe health products; strengthen pharmaceutical sector capacity in countries that manufacture products for low- and middle-income countries and/or local supply; define local production and develop model strategies for quality-assured medicines and other health products, including by strengthening regulatory oversight and quality local production; strengthen post-market surveillance for the quality, safety and efficacy of health products in order to improve the prevention and detection of, and the response to, substandard and falsified medical products; disseminate product alerts; strengthen national and regional regulatory procedures for risk-based evaluations during public health emergencies; develop and adopt regulatory preparedness for public health emergencies; and use regional networks for expedited evaluations of regulatory preparedness. In producing global public health goods, the Secretariat will: strengthen and expand WHO?s prequalification lists, including the List of In Vitro Diagnostics; continue to develop processes and procedures for the prequalification of vector-control products; develop new pathways to prequalification listing and new risk-based approaches to support time-limited procurement; develop technical guidance to expand the scope of prequalification for all product streams and expand the range of products eligible for prequalification in order to ensure that the low- and middle-income country context is a driver of innovation and product development; and develop relevant regulatory tools, guidelines and practices, as well as platforms and pathways, to facilitate the registration of medicines, vaccines and diagnostics through joint reviews and emergency use listing.