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ProjTitle.icon 1. Introduction

Pharmaceutical and biological products submitted for SFDA’s assessment and authorization must meet many aspects of quality, safety and efficacy. The overall evaluation process depends on the quality of submitted relevant clinical data. Assessment of the benefit-risk balance of products depends on evaluating the clinical components of the application. All pharmaceutical and biological products intended for human use must undergo certain clinical testing via a series of studies to establish their safety and efficacy profile. The number and type of studies needed depends on the type of application. This document describes the clinical data required for drug registration at the Saudi Food and Drug Authority (SFDA).

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