Egypt’s EDA digitises drug registration process

The Egyptian Drug Authority’s (EDA) head Ali Ghamrawy witnessed a key cooperation protocol between Digital Access to Finance (DAF) company and EXTEDO for the Electronic Common Technical Document (E-CTD) project.

This initiative addresses existing challenges within the health sector by transitioning from paper-based file submissions to a fully electronic system, according to a statement published by the Cabinet.

The new electronic registration system is designed to expedite the submission and review of registration files, ultimately reducing the time required for new products to reach the Egyptian market.

The digital platform tracks submitted files accurately, enhancing transparency between companies and the EDA. It also enables information exchange with international regulatory bodies, boosting Egyptian pharmaceutical exports globally.

The protocol offers companies automated and flexible options for updating and resubmitting data, positioning Egypt as a leader in drug regulation and registration in line with the World Health Organization (WHO) standards.

Ghamrawy emphasised the EDA’s ambitious digitalisation strategy and its commitment to accelerating digital transformation and maximising the benefits of digital solutions, the statement added.

Furthermore, he stated that this approach significantly contributes to supporting good governance, enhancing institutional excellence, and modernizing administrative operations within the EDA.

The goal is to ensure customer satisfaction for pharmaceutical companies and provide a rapid response to their needs, ultimately reducing effort, time, and associated costs while ensuring high-quality service delivery.

He affirmed that partnerships with private companies are essential for driving the pharmaceutical sector forward and achieving optimal outcomes for all stakeholders, ultimately benefiting Egyptian patients.

Attribution: Amwal Al Ghad English

Subediting: M. S. Salama