The study concerned 18 medicinal products that were withdrawn, revoked or suspended in the EU for safety reasons following the implementation of new pharmacovigilance legislation on 1 July 2012 until 31 December 2016. We examined the publicly-available evidence cited and found that several sources of evidence supported most (17/18) regulatory actions. Our results suggested that the number of drug withdrawals has dropped since July 2012 and that there has been a small reduction in the time taken to reach a decision to withdraw, suspend or revoke a marketing authorisation. This may imply that a stated aim of the updated legislation (“rapid and robust assessment of issues related to the safety of medicines”) is beginning to be achieved, although only tentative conclusions can be drawn due to the small sample size.
This work builds on two previous DSRU studies which examined reasons for drug withdrawals in 1999-2001 and 2002-2011, and is part of a commitment to the ENCePP Special Interest Group on Measuring the Impact of Pharmacovigilance Activities.
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