The Egyptian Drug Authority (EDA) participated in the meeting of the Technical Committee (TC) Leaders of the Global Harmonization Working Party (GHWP), held in Tashkent, Uzbekistan.
This participation comes within the framework of the EDA’s commitment to strengthening international cooperation and exchanging expertise in the regulation of medical devices and supplies, as well as supporting efforts aimed at advancing the regulatory system and enhancing its efficiency in line with international standards.
During the event, Dr. Rania Soliman, General Manager of the Medical Devices Marketing Authorization Administration at the Egyptian Drug Authority, delivered a presentation in her capacity as Technical Committee Co-Chair, during which she reviewed the organization’s training plan. She also chaired the closing session of the meeting. The sessions addressed several key topics, including updates from the annual meeting, developments in export coordination mechanisms among member states, regulatory frameworks governing the circulation of medical devices and supplies during emergencies, as well as the application of artificial intelligence in medical devices.
The meetings of the GHWP Technical Committee reflected a significant shift from establishing harmonized regulatory standards toward enabling their practical implementation at the local level, while emphasizing the importance of digital infrastructure, change management, and collaborative design in bridging gaps among different regulatory systems.
The meeting also addressed several key pillars and strategic outcomes reflecting the group’s direction toward strengthening global regulatory integration. Discussions focused on the global implementation of the Unique Device Identification (UDI) system through the harmonization of regulatory frameworks among countries and linking identification data to supply chains, thereby enhancing patient safety.
In addition, the meeting discussed challenges related to the adoption of regulatory guidelines, particularly in resource-limited countries. Practical solutions were proposed to overcome obstacles such as technical isolation, legal constraints, and market burdens through the development of training programs, the exchange of digital models, the activation of regulatory sandboxes, and support for small and medium-sized enterprises through standardized compliance tools.
The meeting further addressed the development of governance and regulatory procedures by enhancing collaborative mechanisms within technical committees and defining priorities for the upcoming phase. These priorities included export coordination, emergency supply chain management, and the development of preliminary regulatory frameworks for artificial intelligence applications in medical devices. Discussions concluded by emphasizing the importance of strengthening regulatory reliance through leveraging the expertise of reference authorities to support emerging regulatory bodies, thereby improving assessment efficiency, accelerating procedures, and achieving more effective global regulatory harmonization.
This participation comes as part of the Egyptian Drug Authority’s pivotal role in strengthening pharmaceutical and medical regulation globally, supporting efforts to harmonize standards and develop joint working mechanisms, ultimately contributing to enhancing the efficiency of regulatory systems and ensuring the safety and quality of medical devices worldwide.