Published 4 years ago
Last updated 4 years ago
Dr. Al Amiri: ‘UAE becomes second country in the MENA region to deploy the system’His Excellency Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Policy and Licensing Sector for the UAE Ministry of Health and Prevention, and Vice Chairman of the Medical Licensing Committee, emphasized that the need to consolidate technical filing requirements for the registration of drugs in the country is a topic of critical importance as the Ministry continues to develop its services in accordance with the new strategy. He stated that the Ministry will continue to leverage modern technology to provide accurate and excellent services in the implementation of smart electronic systems in line with the vision of the UAE government. The announcement came on March 3, 2016 when the Ministry became the second country in the MENA region to implement the Electronic Common Technical Document (eCTD). H.E. Dr. Al Amiri pointed out that the eCTD will audit and archive various medicines that are distributed by international companies within the UAE by downloading information in servers of the Ministry’s IT department. The Electronic Common Technical Document (eCTD) The medicine’s file is provided through Electronic Common Technical Document (eCTD), which includes safety, quality and studies conducted on the medicine before it is submitted to the Ministry. The eCTD is applied to all the pharmaceutical global bodies such as the U.S. Food and Drug Administration, European Medicines Agency and Pharmaceuticals and Medical Devices Agency (JAPAN) and other countries as well--making it easier to study the content of the medicine and to ensure its safety and quality. H.E. Dr. Al Amiri added that the Ministry seeks to facilitate the registration procedures of products from these global companies through the activation of eCTD, making it easier on the global and regional pharmaceutical companies and factories to evaluate its products. Dr. Al Amiri stated that the Ministry has provided all the electronic equipment and systems to provide a data base that can accommodate medicines registration to reduce the time and effort. Workshops & technical training for those involved in drug administration H.E. Dr. Al Amiri said that the Ministry organized a workshop in collaboration with EXTEDO to introduce the program and working mechanism of the eCTD to all staff involved in drug administration. It issued a statement explaining its action plan and granting a period of time to organize their files accordingly. Seminar for all international & local companies To ensure that local and international companies operating in the UAE benefit from their strategic partnership with the Ministry of Health and Prevention, it has organized a seminar nearly six months ago. In addition, it met pharmaceutical factories to discuss the global electronic transformation and brief them about its importance according to the circular issued by the Ministry. Implementing eCTD to facilitate global & local companies’ work The Ministry has directed all pharmaceutical and healthcare services companies to present all the new registry files for medicines according to the format and structure of the eCTD starting from March 3, 2016. From July 1, 2016, file will be accepted only in the eCTD format. When submitting the file, the company should provide a ‘validation report’ and ‘empty virus report.’ Module 1 must be modified in accordance with the specification issued by the Executive Office of the GCC to include additional requirements under ‘additional data’ section. In case of inquiries during the evaluation of new files, which requires an amendment in registration, the applicant needs to amend and update the original file The registration and amendments must be renewed in the form of eCTD and what has been approved must be carried out in accordance with established procedures for the registration renewal. The medicines registered before March 3, 2016, without the eCTD and presented to the ‘drug administration’ through Module 3 and Module 1 files, must renew its registration only in two formulas--eCTD or NEES. The renewal of the registration or modification will start on January 1, 2017. It must be presented with a letter stating that there were no changes before this procedure, which needs to be submitted for approval in accordance with the applicable guide. Therefore, all companies must provide new files or registration renewals at the Ministry’s headquarters in Dubai.