Pharmaceutical Drug Registration Procedure and Approval Process in Saudi Arabia

Abstract

Human drugs or generic pharmaceuticals drug play a pivotal role in preserving public health, effectively preventing and treating illnesses, disabilities, and fatalities each year. Timely access to these medications is crucial for ensuring the well-being of populations. However, the diverse regulatory landscapes and procedural complexities in developing and emerging nations often hinder the registration and subsequent marketing authorization of high-quality, safe, and effective human drugs, leading to significant delays. This article aims to elucidate the registration prerequisites and approval procedures for human drugs in Saudi Arabia. It delineates the clear pathway for the submission and approval of dossiers intended for marketing authorization applications. Module 1 of the Common Technical Document (CTD) aligns with international standards such as the International Council for Harmonization (ICH) with exceptions noted for certain tests specific to human drugs. The dossier should comprehensively detail the human drug and present the findings of all relevant developmental studies. Understanding the registration requirements and the current regulatory review process administered by the Saudi Food and Drug Authority (SFDA) is essential. This involves identifying the agency's review models, key milestones, and associated timelines to navigate the approval process efficiently.