Comprehending Global Drug Development guidelines through FDA’s spectacle
In the pharma Regulatory arena, the ICH guidelines alongside the health authorities play a pivotal role in ensuring drug product safety and efficacy. However, with the global reach of the pharmaceutical industry, harmonizing Regulatory standards across diverse regions has become a critical imperative. This is where the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) steps in, collaborating with the FDA to streamline global drug development.