The Egyptian Drug Authority (EDA) has maintained its African leadership at Maturity Level 3 (ML3) for the regulation of medicines and vaccines following a follow-up visit by a World Health Organisation (WHO) expert team last week.
The visit, held under ongoing EDA-WHO co-operation, reviewed updates to Egypt’s regulatory framework and the Authority’s development and improvement efforts in line with the WHO Global Benchmarking Tool (GBT).
The EDA said the visit formed part of periodic monitoring of its regulatory maturity and assessed the continued implementation of the systems and practices that enabled Egypt to achieve ML3.
Maintaining this status is part of an ongoing development strategy to enhance the efficiency of the Egyptian regulatory system and ensure it keeps pace with international best practices and standards.
The authority stressed that the effectiveness of Egypt’s regulatory system is not a temporary achievement linked to a single evaluation.
It considers WHO requirements an ongoing framework for institutional and regulatory improvement, while viewing WHO visits as a constructive tool for co-operation and development towards Maturity Level 4.
The EDA aims to complete the current development cycle within 180 days under a specific action plan covering the development of existing regulatory practices and fulfilment of improvement requirements under the WHO ML3 framework, paving the way for achieving ML4.
The authority emphasised that strong regulatory institutions must continuously evaluate and improve themselves, which it said it welcomes.
Such efforts aim to maintain the safety, quality, efficacy and security of medicines and strengthen confidence in Egypt’s pharmaceutical system locally, regionally and internationally.
The EDA reaffirmed its commitment to consolidating Egypt’s position as a leading country with a sophisticated and reliable pharmaceutical regulatory system, supporting confidence in Egyptian medicines, strengthening their competitiveness and enhancing access to regional and international markets.
