Press Release: European Medicines Agency acts on deficiencies in Roche medicines-safety reporting

Author (Corporate)
Series Title
Series Details EMA/405725/2012 (21.6.12)
Publication Date 21/06/2012
Content Type

The European Medicines Agency (EMA), in June 2012, was working with national medicines agencies to investigate deficiencies in the medicine-safety reporting system of Roche. This included looking at whether the deficiencies had an impact on the overall benefit-risk profile for any of the products involved. The deficiencies were identified in a May 2012 report from the UK medicines regulatory agency (MHRA) following an inspection at Roche. This was part of a coordinated European programme of routine inspection of safety reporting systems.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/06/news_detail_001539.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/405725/2012 (21.6.12): European Medicines Agency acts on deficiencies in Roche medicines-safety reporting http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/06/WC500129047.pdf

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