The growing global pharmaceutical care practice has been playing a crucial role in promoting patient health and ensuring quality and safe pharmaceutical products, a sufficient supply of which are required in the UAE to help maintain the well-being of its citizens and residents. 

In light of this, Dr. Amin Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing, Ministry of Health, revealed that the Ministry has signed a contract with German company Extedo to implement an electronic system designed to register different kinds of medicines in the UAE in line with its efforts to develop new strategy for improved service delivery. Dr. Al Amiri maintained that the Ministry will continue to harness the power of modern technologies for accessible, accurate and distinct provisions of services as part of the UAE Government’s vision of deploying ‘smart’ systems. 

Dr. Al Amiri clarified that the electronic system is designed to register various traded pharmaceutical items inside the UAE for international companies. The medicine records will be uploaded electronically to the Ministry of Health’s information technology (IT) systems to avoid paper files. 

Electronic Common Technical Document (eCTD)

The Electronic Common Technical Document (eCTD) application will help pharmaceutical industry to transfer regulatory information from global health agencies. The information includes the safety and quality of the drugs and the studies made on the products before they are submitted to the Ministry for evaluation. The system of unified technical pharmaceutical files is applied by the US Food and Drug Administration, the European Medicines Agency, the Japanese Medicines Agency, and other global bodies. The system enables residents to study the content for safety and quality purposes. 

Dr. Al Amiri said the Ministry of Health will activate the Unified Registry File, making it easier for international companies to submit their technical requirements for evaluation. The system also offers local companies an opportunity to provide health agencies of other countries with similar technical files. The Ministry has put in place all essential equipment and tools, from systems to data base, to ensure smooth registration of medicines and reduction of time and procedure for better delivery of service. 

Extedo

German company Extedo specializes in the design of health programs and is represented by the Modern Pharmaceutical Company in UAE, which designs a unified technical program for drug registration for many European Union countries, Canada and the US. The company was selected based on its past experience in developing ECTD for global use. GCC drug agencies also chose Extedo based on the recommendations made by the Executive Office of the GCC following the latter’s visit to assess its capabilities. Extedo will also train Ministry employees specializing in pharmacological registry and analysis. 

Workshops 

The Ministry will organize a series of workshops in cooperation with Extedo to introduce the program and its mechanisms as well as give a brief about its offices, agencies, and factories for smooth implementation of the system. Additionally, it will showcase the success stories of many organizations using the program.