Examination of the Regulatory Frameworks Employed by SFDA and MHRA: An analysis of the Market Authorisation Application (MAA) Approval Processes.

Abstract

Introduction: Regulatory processes in the pharmaceutical industry play a crucial role in ensuring the quality, safety and efficacy of medicinal products in the modern society. These processes outline the necessary steps applicants must follow to obtain approval for clinical trials, marketing, and manufacturing. Saudi Arabia's Food and Drug Authority (SFDA) recently released its Fourth Strategic Plan, emphasising three major themes, i.e. product safety, local and international partnerships and operational excellence. Methods: This study used secondary research to compare the market authorisation processes of Saudi Arabia's SFDA and the United Kingdom (UK)'s Medicines and Healthcare products Regulatory Agency (MHRA). In addition, this study also utilised a detailed case study, i.e. the commercialisation of Luxturna in Saudi Arabia and the UK, to compare the performances of both regulatory authorities regarding approval timelines and analyse the impacts of market authorisation application (MAA) approvals on patient access and public health. Results: This study identified challenges faced by both authorities and assessed the feasibility of adapting MHRA's measures to improve SFDA's operations. Implications: By examining the regulatory details of both agencies, this study enhanced the understanding of the regulatory considerations of both authorities, and provided recommendations to accelerate the SFDA’s MAA processes, ultimately contributing to better public health outcomes in Saudi Arabia.