Additional risk minimisation measures for medicines approved in the EU
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Additional risk minimisation measures for medicines approved in the EU There appears to be a low probability of introducing or discontinuing additional risk minimisation measures (aRMMs) for new drugs authorised for use in the EU, according to findings of a study published in Drug Safety. Data from European Public Assessment Reports on the European Medicines Agency website were used to investigate post-authorisation introductions of new aRMMs and discontinuations of existing aRMMs for all 476 new drugs authorised in EU between 2006 and 2017. Medicines were followed from the date of marketing authorisation until first introduction or discontinuation of aRMMs, excluding Direct Healthcare Professional Communications (DHPCs). Overall, 91% of new drugs were granted regular marketing authorisation (MA), 4% were granted conditional MA, and 5% were granted MA under exceptional circumstances; aRMMs were required at the time of authorisation for 27% of the drugs. The 5-year probability of introducing aRMMs after authorisation of drugs authorised without aRMMs was 3.5%, and the 10-year probability was 6.9%. For drugs authorised with aRMMs, the 5-year probability of discontinuation of aRMMs was 0.9% and the 10-year probability was 8.3%. "We found low probabilities of introduction and discontinuation of aRMMs (excluding DHPCs) during the product life cycle for medicines authorised between 2006 and 2017. The low rate of discontinuation may potentially be due to a lack of robust data on effectiveness of aRMMs," concluded the authors. Francisca RDC, et al. Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe. Drug Safety : 30 Sep 2020. Available from: URL: http://doi.org/10.1007/s40264-020-00993-6 803507716
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Reactions 17 Oct 2020 No. 1826
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