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No abnormalities found in Roche Company investigations

(People's Daily Online)

08:15, July 17, 2012

Recently, U.K. media reported that the multinational pharmaceutical enterprise Roche Company is being investigated emergently by European drug supervision departments for concealing the report of 15,000 drug fatalities and 65,000 adverse drug reactions. The State Food and Drug Administration of China (SFAD) said on July 11 that it was paying close attention to this incident, and according to China's adverse drug reaction monitoring, no abnormality has been found regarding the drugs involved in the incident.

According to sources, this incident involves eight kinds of drugs, which are mainly used for treating such diseases as the mammary cancer, intestinal cancer, hepatitis, skin diseases and eye diseases.

Of these drugs, the Herceptin for treating mammary cancer, Mabthera for treating malignant lymphoma, Pegasys for treating hepatitis C, Avastin for treating rectal cancer and Tarceva for treating lung cancer are sold in China. These drugs have been in the Chinese market for several years or even more than 10 years.

The SFDA said that no abnormality has been found in China's adverse reaction monitoring on the drugs involved in this incident.

After the incident occurred, the Roche Company made a statement on July 11, saying that the incident of 15,000 adverse reactions of no safety assessment reported by the media was only limited in an U.S. project supported by patients. According to the current assessment by the Roche Company, there is no sign showing drug products of the Roche Company are unsafe.

Medical experts said that normally medicines must be tested by three institutions, namely the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Medicines and the U.K. Healthcare Products Regulatory Agency (MHRA) before they are exported to China. However, these medicines must also pass through the State Food and Drug Administration of China.

As Chinese people are different with foreigners in physique characteristics, foreign data cannot be directly used in China and must pass through China's testing institutions.

Read the Chinese version: 药监局:罗氏隐瞒患者死亡涉及药品未现异常


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