Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines.
At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.
"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine," the EMA said in the statement on Thursday.
"There is, at present, no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or health care professionals to take any action," added the EMA.
A Roche spokesman said the company acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.
http://www.medicalobserver.com.au/news/eye-on-roche-after-failure-to-report-side-effects
