| Author (Corporate) | European Medicines Agency |
|---|---|
| Series Title | Press Release |
| Series Details | EMA/405725/2012 (21.6.12) |
| Publication Date | 21/06/2012 |
| Content Type | News |
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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. |
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| Source Link | http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/06/news_detail_001539.jsp&mid=WC0b01ac058004d5c1 |
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| Subject Categories | Business and Industry, Health |
| Countries / Regions | Europe |
