IRP 2019 8.4.2

Conducting regulatory reviews of novel therapies in a timely manner is essential to improve public health concerns and ensure medical needs are met. There are regulatory mechanisms in place worldwide to accelerate the delivery of treatments for patients with serious diseases or unmet medical needs.

Many regulatory authorities throughout the world have implemented pathways that aim to expedite the submission or the review of products that cater to these medical needs. Understanding how to utilize expedited regulatory paths like Breakthrough Therapy Designation, PRIME, and Sakigake Designation is imperative to make an informed decision about the best ways to accelerate drug development.

These regulatory options are available to ensure regulatory bodies allocated the resources to review and approve therapies as soon as the benefits justify any risks. ExL’s 2nd Innovative Regulatory Pathways will serve as a platform to discuss and compare the current regulatory pathways that allow for earlier attention to drugs that have promise in treating serious or life-threatening conditions.