Author(s): Gidron M
Awareness of drug safety issues has risen to unprecedented levels in light of some of the drug recalls and adverse events that have occurred in recent years. The result has been new legislation, stricter regulations and revised company strategies in Europe and the U.S. These trends have led to greater regulatory uniformity in the EU, which means greater challenges for the pharmaceutical industry. A company can look forward to improved reporting and an overall enhancement of the quality of the EU regulatory system. If there is a lesson to be learned from recent industry crises, it is that bad things can happen to the best companies. When bad things happen, companies need to have a system in place that will take them through the crisis, including a good communication plan. That includes increasing their understanding of the European Medicines Agency (EMEA) and how the EU system operates. As is often the case when working with governments, education is a key factor, so this issue of The Food & Drug Letter focuses on drug safety in the EU.