Regulatory framework for fast track approval of Drugs in different countries

This review aims to analyze and compare the regulatory frameworks for fast-track drug approval in various countries, focusing on the US, Europe, Japan, and Australia. The study highlights the significance of expedited drug approval pathways in addressing unmet medical needs while ensuring safety and efficacy. A detailed evaluation of the standard approval pathways is performed to provide context, followed by a comparative analysis of fast-track mechanisms. Challenges associated with these programs are also explored. The study identifies similarities & differences in expedited drug approval pathways across countries, highlighting unique features of the Fast Track Designation in the U.S., PRIME in Europe, Sakigake in Japan, and Priority Review in Australia. Despite their effectiveness in accelerating drug availability, challenges such as balancing speed with rigorous evaluation, regulatory inconsistencies, and resource allocation are evident. Expedited approval programs significantly impact public health by improving access to innovative therapies. However, harmonizing regulatory processes and addressing associated challenges are crucial for optimizing their implementation globally.