Roche Drug Safety Reporting System Probed by EU Medicines Agency
The European Medicines Agency (EMA) is investigating Roche ’s drug safety reporting system after an inspection by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) found deficiencies in the Swiss drugmaker’s reporting process. At the time of the MHRA inspection, Roche identified about 80,000 reports for medicines marketed by the company in the U.S. that had been collected through a Roche-sponsored patient support