Note sull'episodio
This episode examines the key differences in regulatory requirements across major global markets, including the US (FDA), Europe (EMA), Japan (PMDA), and China (NMPA). We explore efforts towards global harmonization through the ICH (International Council for Harmonization) and discuss the challenges of aligning standards across different regions. We touch on pre-clinical data, clinical trials, bioavailability, and bioequivalence studies.
The conversation highlights the impact of these variations on drug development timelines, regulatory bottlenecks, and ultimately, patient access to new medicines. Real-world case studies are used to illustrate both successes and setbacks in international regulatory alignment, providing both industry and patient perspectives. The episode also explores the influence of emerging technologies and trends on the ...