Hot on the heels of announcing it was joining Project Orbis, the UK drug regulator, the MHRA, now says it will join another international collaboration that allows drug companies to submit medicines for review by several countries at the same time.
The UK medicines regulator, the MHRA, is joining yet another established international regulatory collaboration for speeding up drug evaluations when the Brexit transition period ends – this time the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
The move was revealed on 14 October, just over a week after the UK government announced that the MHRA was...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
