08 October 2024 | News
This initiative is expected to shorten the timeline for bringing new treatments to market
The Emirates Drug Establishment (EDE) has entered into a Memorandum of Understanding (MoU) with the Korean Ministry of Food and Drug Safety to bolster collaboration in the pharmaceutical manufacturing and medical products sectors.
The MoU focuses on exchanging expertise between the UAE and Korea in crucial areas such as drug regulation, best practices, clinical trials, and pharmacovigilance. The goal is to uphold the highest standards of quality and safety in medical products.
The agreement was formalised by Dr Fatima Mohammed Al Kaabi, Director-General of EDE, and Joon-Su Shin, General Director of the Korean Ministry of Food and Drug Safety, in the presence of officials from both organisations.
This MoU aims to expedite the registration process for pharmaceutical products in both nations by introducing a fast-track approval process for early-stage products that have received endorsements from international regulatory authorities, including those from the European Union, the United States, and Japan.
This initiative is expected to shorten the timeline for bringing new treatments to market, ultimately benefiting patients by providing quicker access to innovative therapies.
Additionally, the agreement seeks to improve post-marketing surveillance systems to identify and address quality defects or safety concerns with medical products. This includes creating early warning mechanisms to detect counterfeit or defective products, ensuring prompt action to mitigate potential public health risks.
The MoU also facilitates the exchange of findings from clinical and non-clinical research, studies, and trials to enhance scientific and technological cooperation in drug development. This includes research focused on creating innovative biomedical drugs that meet the needs of communities in both countries.
Furthermore, the agreement outlines mutual training programmes designed to enhance the skills of personnel within the pharmaceutical industry. It calls for regular visits to pharmaceutical facilities in both nations to share practical and technological experiences, emphasizing the importance of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).