Stricter review of high-risk devices to support Australia's HTA assessment
This article was originally published in RAJ Devices
Australia’s Therapeutic Goods Administration has been asked to introduce by 2011 more rigorous pre-market approval requirements for higher-risk devices to satisfactorily establish the safety of these products before they are assessed for cost and clinical benefits by health technology bodies1,2.
You may also be interested in...
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.
Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.