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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.

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