UAE Ministry of Health & Prevention implements Electronic Common Technical Document system to improve registration of pharmaceutical products

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 have to consolidate technical filing requirements for the registration of drugs in the country is a subject of vital importance as the Ministry continues to establish its services in accordance with the brand-new method. He mentioned that the Ministry will remain to leverage contemporary innovation to provide precise and exceptional services in the implementation of smart electronic systems in line with the vision of the UAE federal government.

The announcement came on March 3, 2016 when the Ministry became the 2nd country in the MENA area to execute the Electronic Common Technical Document (eCTD). H.E. Dr. Al Amiri pointed out that the eCTD will investigate and archive various medicines that are distributed by worldwide companies within the UAE by downloading information in servers of the Ministry's IT department.

The Electronic Common Technical Document (eCTD).
The medication's file is offered through Electronic Common Technical Document (eCTD), that includes security, quality and research studies performed on the medicine prior to it is submitted to the Ministry. The eCTD is applied to all the pharmaceutical global bodies such as the United States Food and Drug Administration, European Medicines Agency and Pharmaceuticals and Medical Devices.

Agency (JAPAN) and other nations too-- making it much easier to study the material of the medication and to guarantee its safety and quality.

H.E. Dr. Al Amiri added that the Ministry seeks to facilitate the registration procedures of items from these worldwide companies through the activation of eCTD, making it easier on the worldwide and regional pharmaceutical business and factories to assess its products. Dr. Al Amiri mentioned that the Ministry has actually offered all the electronic equipment and systems to offer a data base that can accommodate medications registration to lower the time and effort.

Workshops & technical training for those involved in drug administration.
H.E. Dr. Al Amiri stated that the Ministry arranged a workshop in collaboration with EXTEDO to introduce the program and working system of the eCTD to all staff involved in drug administration. It issued a statement explaining its action strategy and giving an amount of time to organize their files appropriately.

Seminar for all international & local companies
To guarantee that regional and worldwide companies running in the UAE gain from their strategic partnership with the Ministry of Health and Prevention, it has organized a seminar almost 6 months ago. In addition, it fulfilled pharmaceutical factories to discuss the worldwide electronic transformation and brief them about its value according to the circular provided by the Ministry.

Implementing eCTD to facilitate global & local companies work
The Ministry has actually directed all pharmaceutical and health care services business to present all the brand-new computer system registry files for medicines according to the format and structure of the eCTD beginning with March 3, 2016. From July 1, 2016, file will be accepted only in the eCTD format.

When submitting the file, the company ought to provide a validation report and empty virus report.' Module 1 has to be customized in accordance with the specification issued by the Executive Office of the GCC to include additional requirements under 'additional data' section. In case of queries during the assessment of new files, which requires an amendment in registration, the candidate needs to modify and upgrade 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 Ministrys headquarters in Dubai.