Impact of Digitalization in strengthening the regulatory functions of NAFDAC: Opportunities and Challenges for other National Regulatory Authorities

Abstract

The digitalization stride employed by the National Agency for Food and Drug Administration and Control (NAFDAC) as a National Regulatory Authority (NRA) to strengthen its regulatory functions represents a paradigmatic shift from a primordial method to digital innovation and automation of its regulatory processes. This review X-rays the impact of digitalization and automation of regulatory functions in NAFDAC and the significant contribution of digital innovation to the landmark achievements of the Agency as a WHO-ML3 NRA and one of the NRAs in the world with a Prequalified Laboratory by the World Health Organization. This synopsis also examines the technological components of digitalization deployed by NAFDAC and the inherent opportunities. Notably, some of the gains from digital innovation include promoting regulatory efficiency, data integrity, improving efficient management of human resources, minimizing the prevalence of Substandard and Falsified Regulated Products, improving real-time access to regulatory information, enhancing transparency, and improving public confidence. In other ways, digitalization strengthens regulatory collaborations between the Agency and other NRAs around the globe. The discourse further evaluates the role of digitalization in the assessment of regulatory functions of NRAs for Global Benchmarking Tools and Maturity levels by the World Health Organization and summarizes challenges in the digitalization of regulatory functions. Thus, embracing digital innovations, and modern technologies in regulatory processes is a transformative and innovative strategy to promote regulatory efficiency, data integrity, and effectiveness in strengthening the regulatory functions of NRAs.