Events
EDA participates in the Gulf Regulatory Affairs Summit 2024, the ninth edition
"The Egyptian Drug Authority (EDA) announced its participation in the 9th edition of the GCC Regulatory Affairs Pharma Summit 2024, which was held in the United Arab Emirates to exchange information, transfer experiences between pharmaceutical regulatory authorities, and present the most important updates to the regulatory frameworks, rules and procedures related to the registration of human products, pharmacovigilance, and quality management system.
During the sessions, representatives of the Authority reviewed the regulatory guides, activities and programs related to the various areas of regulatory work entrusted to the Authority, related to the nature of the regulatory authority's work, and the latest rules followed in the field of registration, safety and quality of pharmaceuticals.
The conference explained the regulations of registration of human pharmaceuticals, the most important updates of the EDA Chairman's decrees regulating the registration and re-registration process, and presented the EDA's vision of the importance of Good Registration Practices (GRP); and highlighted the EDA variation self-guided tool , where this innovative digital platform enhances transparency and effectiveness within the regulatory system, and how these smart digital tools empower stakeholders and enhance the effectiveness of the system as a whole.
The conference also reviewed the field of pharmacovigilance, presented the Egyptian Guideline on good pharmacovigilance practice, and the most important updates in line with the most important global guidelines updates, and presented the most important means and all channels and mechanisms of communication with health care providers, patients, and the public, the objectives, principles and plan of communication means, and emphasized the importance and necessity of cooperation between the authority, companies, and health care providers to enhance the safety and efficacy of medicines.
It also introduces the quality management system and its significance. The session also highlighted the essential strategies employed to improve commercial quality standards, along with the primary strategies adopted by the EDA to strengthen its regulatory system. These strategies have a positive impact on the quality of pharmaceutical products before they are introduced to the Egyptian market.
During the conference, the Authority reviewed the experience of the Arab Republic of Egypt in the field of modernizing and developing the rules and procedures of drug registration, pharmacovigilance, and quality systems, and the impact of this on the availability of effective, safe, and quality medicines in the Egyptian market.
The participation came within the framework of the Authority's continuous endeavor to support all means of cooperation with brotherly Arab countries and keenness to participate in various international events in the field of medicine."
Tags
The Egyptian Drug Authority (EDA)
the Gulf Regulatory Affairs