A new list of national regulators that want to be seen as meeting the highest international regulatory standards has been drawn up by the WHO in a drive to foster regulatory convergence and harmonization.
The World Health Organization is preparing to introduce its new framework for designating national regulatory agencies as “WHO-Listed Authorities” (WLAs) – those that meet WHO and internationally recognized standards and guidelines as well as following good regulatory practices.
National regulators will be evaluated over the coming five years using the latest version of the WHO’s Global Benchmarking Tool...
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
