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Summary of EC report on use of medicinal products for human use

European Commission report – “Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012-2014)”

The EU Commission has published the above titled report on 8th August 2016 which describes the activities of the EU’s networked and collaborative system for monitoring and controlling the safety of human medicines and is focused on activities since the start of operation of new legislation in 2012 until the end of 2014, but also includes information on some tasks and processes initiated up to July 2015.

In summary the report shows:

  • Number and types of information reviewed by Pharmacovigilance Risk Assessment Committee (PRAC) – Aggregate Reports and Risk Management plans forming the main volume of documents reviewed. Interestingly a very small proportion of information involved Regulatory Inspections (2011 = #207; 2014 = #167) however details of this type of information were not provided

  • Assessment of Signals was another key factor addressed in the report. Of interest was that only one Post Authorisation Safety Study (PASS) was required as a result of the review and only two RMPs required updating

  • Serious Individual Case Safety Report (ICSR) volumes were outlined. Interestingly ICSRs reported by Patients and Health Care Practitioners (HCP) in Non-EEA countries increased from 2011-2014.

The full report can be downloaded from the EMA website

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