In order to bring innovative biopharmaceutical to the global market companies must navigate the unique regulations of each country they seek to enter. This enormous regulatory hurdle delays access to the newest innovations and is a primary reason patients in the U.S. often have access to life saving therapies years before they are available anywhere else.
Lila Feisee BIO’s Vice President International Affairs addresses this issue and the International Council on Harmonization’s (ICH) efforts to provide a workable solution to this morass in an article she published in LinkedIn entitled Regulatory Harmonization: Making Innovative Drugs Available Globally.
“While the US is still the most lucrative market for pharmaceuticals by far, this paradigm is changing as China, Brazil and Korea enter as players on the world stage,” says Feisee. “This dynamic will change even more in the coming decade as more and more countries put in place health systems with regulatory authorities. This will not only increase the market potential for pharmaceuticals, but will also intensify the need for streamlined regulations as companies seek approval in these new markets.”