EMA dilutes ambitious data re-analysis plans
This article was originally published in Scrip
The European Medicines Agency has abandoned plans to routinely require and re-analyze original clinical trial data in marketing authorization applications. Instead, it is considering whether it should restrict this exercise to a limited number of cases where "such analysis could significantly strengthen the [EMA's] assessment work".
You may also be interested in...
As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.
The Saudi Food & Drug Authority looks at the number of individual case safety reports (ICSRs) submitted by a company, among other risk-based factors, when drawing up its list for routine pharmacovigilance inspections.