Regulatory convergence and the sharing of dossiers, together with the timely and equitable sharing of pathogens, could help to speed up access to medicines, vaccines and diagnostics in pandemic situations, according to the first draft of the World Health Organization’s proposed pandemic treaty.
The first draft of the pandemic treaty being developed by the World Health Organization says that regulatory requirements for the approval of pandemic response products such as medicines and vaccines should be further harmonized at the global level, and that regulatory dossiers should be shared to speed up the product approval process.
It also calls for countries and stakeholders to promote the “rapid and transparent” sharing of pathogens with pandemic potential and...
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.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
