Regulatory Impact Analysis for the Risk Based Lot Release Policy for Biological Products in Egypt
Keywords:Egyptian drug authority, Reliance, lot release, risk-based, regulatory impact analysis, smart regulations, convergence
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.
Alastair J. Wood and Patricia Cuff, Wood, A. J. J., Cuff, P. A., National Academies of Sciences, E., & Alastair J. Wood and Patricia Cuff. (2020). Regulating Medicines in a Globalized World:The Need for Increased Reliance Among Regulators. In National Academies of Sciences, Engineering, and Medicine.
Dumbravă, V., & Vladut-Severian, I. (2013). Using Probability – Impact Matrix in Analysis and Risk Assessment Projects. Journal of Knowledge Management, Economics and Information Technology, 42(December).
Egyptian drug authority. (2022). Guideline for Lot Release of Biological Products in Egypt 2022.
Gostin, L. O., Wood, A. J., & Cuff, P. A. (2020). Regulating Medicines in a Globalized World with Increased Recognition and Reliance among Regulators: A National Academies Report. In JAMA - Journal of the American Medical Association. https://doi.org/10.1001/jama.2019.21793
Gupta, R. K., Gupta, C. K., & Mallet, L. (2015). Lot release of vaccines by regulatory authorities and harmonization of testing requirements. In Vaccine Analysis: Strategies, Principles, and Control. https://doi.org/10.1007/978-3-662-45024-6_16
Hashan, H. M., Al-Muteb, S. K., Alismail, I. A., Alsaleh, O. N., Alkherb, Z. M., McAuslane, N., & Walker, S. R. (2022). Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality. Pharmaceutical Medicine. https://doi.org/10.1007/s40290-022-00432-0
Jonski, K., & Rogowski, W. (2023). Evidence-Based Policymaking during the COVID-19 Crisis: Regulatory Impact Assessments and the Polish COVID-19 Restrictions. European Journal of Risk Regulation, 14(1). https://doi.org/10.1017/err.2022.18
Kurniawan, T., Muslim, M. A., & Sakapurnama, E. (2018a). Regulatory impact assessment and its challenges: An empirical analysis from Indonesia. Kasetsart Journal of Social Sciences. https://doi.org/10.1016/j.kjss.2017.12.004
Kurniawan, T., Muslim, M. A., & Sakapurnama, E. (2018b). Regulatory impact assessment and its challenges: An empirical analysis from Indonesia. Kasetsart Journal of Social Sciences, 39(1). https://doi.org/10.1016/j.kjss.2017.12.004
McAuslane, N., Bujar, M., Sithole, T., Ngum, N., Owusu-Asante, M., & Walker, S. (2023). Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities. Pharmaceutical Medicine, 37(3), 251–260. https://doi.org/10.1007/s40290-023-00472-0
Moeti, L., Litedu, M., & Joubert, J. (2023). The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA). Pharmaceutical Medicine. https://doi.org/10.1007/s40290-022-00452-w
Rönninger, S. K., & Garbe, J. H. O. (2016). Import testing turned into an unnecessary limitation of patient access to medicines as risks are managed effectively. Pharmaceuticals Policy and Law, 18(1–4). https://doi.org/10.3233/PPL-160439
Roth, L., Bempong, D., Babigumira, J. B., Banoo, S., Cooke, E., Jeffreys, D., Kasonde, L., Leufkens, H. G. M., Lim, J. C. W., Lumpkin, M., Mahlangu, G., Peeling, R. W., Rees, H., Ndomondo-Sigonda, M., Stergachis, A., Ward, M., & Nwokike, J. (2018). Expanding global access to essential medicines: Investment priorities for sustainably strengthening medical product regulatory systems. Globalization and Health. https://doi.org/10.1186/s12992-018-0421-2
Saint-Raymond, A., Valentin, M., Nakashima, N., Orphanos, N., Santos, G., Balkamos, G., & Azatyan, S. (2022). Reliance is key to effective access and oversight of medical products in case of public health emergencies. Expert Review of Clinical Pharmacology. https://doi.org/10.1080/17512433.2022.2088503
WHO Technical Report Series 978. (2013). Guidelines for independent lot release of vaccines by regulatory authorities.
Xu, M., Zhang, L., Feng, X., Zhang, Z., & Huang, Y. (2022). Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific. In BMJ Global Health. https://doi.org/10.1136/bmjgh-2022-009798
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