Dutch drug regulator and HTA body offer integrated scientific advice
This article was originally published in Scrip
The Netherlands has launched a year-long pilot programme allowing drug companies to seek "integrated" scientific advice from the Medicines Evaluation Board and the Healthcare Insurance Board (CVZ).
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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.