The WLA nominations have kicked off a voluntary evaluation process intended to identify “reference” regulatory authorities and improve international reliance and cooperation.
The World Health Organization has announced that the regulatory agencies of Singapore, South Korea and Switzerland have become the first three “WHO-Listed Authorities” under a new framework intended to promote the harmonization of regulatory standards and practices at global level.
The WHO said the decisions were a “significant milestone” for the countries concerned and represented “global recognition that these three...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
