The International Council for Harmonisation has unveiled plans to develop and publish several new guidance documents, including one on bioequivalence for modified-release products, which has been welcomed by global off-patent industry body the IGBA.
Plans announced by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and publish a guideline on bioequivalence for modified-release products have been commended by the International Generic and Biosimilar Medicines Association (IGBA).
Bioequivalence for modified-release products was one of three new areas for harmonization that the ICH assembly adopted at its meeting...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
