Risk minimization activities of centrally authorized products in the EU: A descriptive study
Drug Safety , Volume 35 - Issue 4 p. 299- 314
Background: Since the new legislation on risk management, which came into force in November 2005, an EU Risk Management Plan (EU-RMP) is a required part of the authorization dossier of innovative drugs licensed in the EU. The EU-RMP can include additional risk minimization activities (RMAs) to strengthen the benefit-risk balance of a drug. This study describes the additional RMAs of centrally authorized medicinal products authorized between 1 January 1995 and 1 January 2010. Methods: The European Public Assessment Reports of all centrally authorized products were analysed to identify characteristics of the product (active substance, authorization date, Anatomical Therapeutic Chemical classification), the additional RMAs and the corresponding safety concerns (classified at Medical Dictionary for Regulatory Activities (MedDRA®) System Organ Class level). Results: Additional RMAs were identified for 58 of the 391 active substances that were authorized as of 1 January 2010. The proportion of active substances with additional RMAs was 5% among those authorized before, and 29% among those approved after the new risk management legislation. Since the new legislation, blood products and antineoplastic and immunomodulating agents most often had additional RMAs. All active substances with additional RMAs required the provision of educational material, most frequently involving healthcare professionals (n = 57) and the patient (n = 31). Thirty-three active substances required additional RMAs on top of the provision of educationalmaterial,most frequently including patientmonitoring and screening (n = 19). Conclusions: The proactive pharmacovigilance approach is evolving and the number of products with additional RMAs is growing since the introduction of the EU-RMP. The provision of educational material is the primary additional risk minimization strategy in the EU. The effect of additional RMA implementation has to be explored.
|European-Medicines-Agency, Pharmacovigilance, Regulatory-process, Risk-management|
|Organisation||Erasmus MC: University Medical Center Rotterdam|
Zomerdijk, T.P.L, Sayed-Tabatabaei, F.A, Trifirò, G, Blackburn, S.C.F, Sturkenboom, M.C.J.M, & Straus, S.M.J.M. (2012). Risk minimization activities of centrally authorized products in the EU: A descriptive study. Drug Safety, 35(4), 299–314. doi:10.2165/11594560-000000000-00000