European research-based pharmaceutical industry association, EFPIA, says it "makes sense" for the World Health Organization to review the concept of "stringent regulatory authorities," which is linked to a country's membership of the International Council for Harmonisation.
The World Health Organization is inviting feedback on its proposal to change its definition of "stringent regulatory authorities," which at present is directly linked to a regulatory authority's membership of the International Council for Harmonisation.
The proposal has been prompted by recent structural changes at the ICH, which has resulted in the organization expanding. For...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
