Det heter Accelerated approval i USA (FDA) og Conditional approval i Europa (EMA)
“Accelerated Approval (United States) and Conditional Approval (European Union) are options for applicants to provide preliminary data to Health Authorities in order to support a more limited approval.”
" To qualify for accelerated approval, the drug must treat a serious condition and generally provide a meaningful advantage over available therapies and demonstrate an effect on a surrogate end point that is reasonably likely to predict clinical benefit or on an intermediate clinical end point that can be measured earlier than irreversible morbidity or mortality that is reasonably likely to predict clinical benefit. It is important to note that drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval."
“For drugs granted accelerated approval, postmarketing confirmatory trials have been required to verify and describe the anticipated clinical benefit.”
" The EMA also offers a pathway enabling approval based on a more limited data set for new medicines that have the potential to address an unmet medical need.32 Conditional Approval"
"A key aspect of Conditional Approval is that the applicant commits to “Specific Obligations,” which are mandatory postmarketing requirements with specified timelines to ensure that the applicant does eventually provide a comprehensive data set to support “full approval.” "
Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways.