Feedback from two pilot projects involving collaboration by multiple regulators on the assessment of post-approval manufacturing changes and pre-approval drug inspections is expected soon, according to the International Coalition of Medicines Regulatory Authorities.
Industry and regulators are due to discuss their experience with two ongoing international pilot projects that are exploring how multiple regulators can work together to assess applications for post-approval manufacturing changes and collaborate on pre-approval drug inspections respectively.
Regulatory harmonization on these fronts is expected to help maximize resources and facilitate more effective and efficient reviews, noted the...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
