In Focus: Global Harmonization Initiatives
Posted 01 March 2010 | By
The steadily increasing push for drug and device regulatory harmonization worldwide has been driven by many factors, not the least of them economic. It is no longer possible for a country to exist in a bubble, unconcerned about socioeconomic, political and regulatory developments in faraway regions. Neither is it feasible for a pharmaceutical or medical device company to ignore the regulatory infrastructure and requirements of other countries simply because it is not currently importing into or exporting from these areas. This situation could change rapidly.