Growing global regulatory requirements challenge drug developers, says Tufts CSDD

As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate, according to a panel of leaders from the research-based drug industry recently convened by the USA-based Tufts Center for the Study of Drug Development.

"What a company does in one region can very likely affect how regulators treat it elsewhere," said Tufts CSDD associate director Christopher-Paul Milne, adding: "Understanding local regulatory requirements and trends, and how competitors' activities are shaping those trends, has become a minimum requirement for engaging in global drug development."