The European Medicines Agency is moving to reject substitute proof-of-concept trials in place of GCP noncompliant studies during marketing application reviews.
Under the agency’s new stance, if the noncompliant trial forms the sole basis of the application, drugmakers would not be able to provide another study and would instead have to resubmit another application.
In cases discovered postapproval, the EMA says it could take action on the drug but would first consider the potential harm posed by pulling it, as well as the strength of the overall evidence and whether the maker can provide further data.
“This position highlights the importance for the applicants and MAHs of being able to demonstrate compliance with GCP standards, which provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that generated data are robust,” the agency says in a position paper this week.
Offering a route for drugmakers whose studies failed inspections, the EMA will allow applicants to reanalyze data and offer rebuttals on why the trial findings are sound. The Committee for Medicinal Products for Human Use will take these additional materials into account in its formal benefit-risk assessment.
The EMA’s full position paper can be read at www.fdanews.com/12-02-15-EMA.pdf.