Apps in this category may contain mild or occasional cartoon, fantasy or real-life violence, as well as occasional or mild adult, sexually suggestive or horrifying content and may not be suitable for children under 9 years of age.

12+

Apps in this category may contain occasional mild indecent language, frequent or intense cartoon or real-life violence, minor or occasional adult or sexually suggestive material, and simulated gambling, and may be for children under 12 years of age.

17+

You must be at least 17 years old to access this App.

Apps in this category may contain frequent and intense offensive language; Frequent and intense cartoon, fantasy or realistic violence: frequent and intense adult, scary and sexually suggestive subjects: as well as sexual content, nudity, tobacco, alcohol and drugs, may not be suitable for children under 17 years of age.

IRP 2019 スクリーンショット

iPhone

About IRP 2019

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.