Saudi FDA To Cut Drug Approval Time With Abridged Reviews
This article was originally published in SRA
Executive Summary
The Saudi Food and Drug Authority is planning to introduce a system of abridged regulatory reviews for drugs that could cut the approval timeline by around 40% and make it easier for companies to both bring their products to Saudi Arabia and produce them locally. In another move, the agency is creating a new department to assess benefit-risk profiles and a new risk assessment model.