The EMA’s process for assessing medicines for use in non-EU countries is being beefed up after a review showed the mechanism had several flaws that made it unattractive to many companies.
The European Medicines Agency is working on ways to entice more pharmaceutical companies to use its “Article 58” procedure, an assessment mechanism that was introduced in 2004 to increase the availability of medicines in non-EU countries with fewer regulatory resources and high unmet medical needs.
Article 58 allows the EMA’s drug evaluation committee, the CHMP, to give a scientific opinion on a marketing authorization application...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
