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UAE Ministry of Health implements eCTD

Electronic Common Technical Document for drug registration introduced

UAE Ministry of Health implements eCTD
The eCTD will help companies to register their pharmaceutical products with the Ministry of Health, says HE Dr Amin Hussein Al Amiri.

The UAE Ministry of Health has announced the implementation of the Electronic Common Technical Document (eCTD), a standardised system to audit and archive medicine in use within the UAE.

The eCTD format allows pharmaceutical companies to register drugs with the Ministry, including a range of clinical information, through an online document. The eCTD includes information on which includes safety, quality and studies conducted on the medicine before it is submitted to the Ministry.

The eCTD is a global standard which is in use by the US Food and Drug Administration, European Medicines Agency and Pharmaceuticals and Medical Devices Agency (Japan) among others. The UAE Ministry of Health is only the second country in the MENA region to implement 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, said that implementation of the eCTD will make it easier on the global and regional pharmaceutical companies and factories to have their products evaluated.

The Ministry has established the systems for drug registration, and a database of medicines registration. It has also conducted workshops and training on the eCTD for all staff involved in drug administration, and seminars for local and international companies on how to use the system.

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