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Saudi Journal of Medical and Pharmaceutical Sciences (SJMPS)
Volume-6 | Issue-06 | 429-434
Original Research Article
Risk-Minimization Measures in the EU: Review of Two Year Period Safety Referral Procedures
Violeta Getova, Ilko Getov
Published : June 14, 2020
DOI : 10.36348/sjmps.2020.v06i06.001
Abstract
The current study aims to research, systemize and analyze the qualitative characteristics of pharmacovigilance referral procedures which took place in the EU for two years period 2017-2018. For the purpose of the study PRAC decisions and minutes for all procedures which started and completed within 2017-2018 were extracted and systemized. The systemization was made based on several criteria including legal basis of procedure, scope, proposed risk-minimization measures. The results from the study showed that the PRAC’s recommendations are most frequently focused on narrowing patient population and therapeutic indications and enhancing safety monitoring during medicines’ use. National competent authorities play major role both as initiators of referrals and national safety monitors. The conducted analysis shows that conducting PRAC safety referral procedure is a complex and dynamic process where real-life clinical data is valuable source of information. The suggested risk-minimization steps are mainly focused on enforcement of measures already existing in the risk-management plan of the products. They also require a constant follow-up monitoring for efficacy. National competent authorities are leading participants in organizing the work and composing the agenda of the committee.
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