Regulatory Impact Analysis for the Risk Based Lot Release Policy for Biological Products in Egypt

Abstract

For public health and lifesaving, timely access to high-quality biological products is essential. However, barriers including resource scarcity, limited human capacity, and complex supply chains impede this goal. National regulatory authorities should enhance their frameworks and move forward for regulatory convergence and harmonization & enhancing reliance practice in order to address these concerns. A risk-based lot release policy is one of the enablers that ensure implementation of smart regulations and best practices was employed by Egyptian drug authority (EDA) to boost the effectiveness of the lot release framework while upholding safety, efficacy and quality criteria. The legal framework for lot release in Egypt was examined using a regulatory impact analysis method. With a considerable impact on time and cost savings, as well as a better net benefit value, the new risk-based lot release policy has the potential to greatly increase the efficiency of Egypt's LR regulatory system for biological products. Nevertheless, significant challenges and unexpected consequences were also noted, including the need for ongoing capacity building and growing regulatory requirements based on best practices. The findings have major reflections for drug policy makers and regulators looking to enhance their biological product regulatory systems; since the policy's benefits outweigh these possible challenges. This paper offers a full examination of the risk-based lot release policy used by the EDA, Egypt for biological products, assisting in understanding both the benefits and challenges of this approach.