Sanofi’s president of global R&D, Elias Zerhouni, said regulatory systems in different regions complicate the global nature of research and manufacturer operations, according to Reuters.
Zerhouni was speaking at a conference in London celebrating the 20th anniversary of the European Medicines Agency (EMA). He told the audience that “in my short experience of five years, I have not seen a single regulatory decision that was fully consistent across regulatory agencies… There are increasing regulatory differences across the regions. It imposes an enormous cost on the innovator. I spend 20% of our R&D budget trying to mix and match in order to do the convergence between different systems.”
He also cited one of his company’s own products as an example, saying the EMA allows Sanofi to make more benefit claims about its new basal insulin Toujeo than the FDA does.