With an announcement made on 3rd March, 2016 by the UAE Ministry of Health & Prevention, UAE becomes the second nation to implement eCTD in the MNEA region. All the pharmaceutical and health service provider companies are asked to follow eCTD structure and format of submission for new registrations of medicines. No new medicine registrations will be accepted in any format other than eCTD from 1st July, 2016 onwards. For UAE, this is an opportunity to leverage the latest technology to streamline and provide uninterrupted services for patients by shifting to eCTD.

Companies are required to submit a “validation report” along with an “empty virus report” during initial submission. The Executive Office of GCC has established the specification for module 1, consisting of additional requirements revealed under the section of “additional data”, according to which the companies are required to update the original documents and submit to the Ministry. Drugs approved before 3rd March, 2016 should adhere to the new guidelines for the renewal process that must align with eCTD or NeeS specifications. These renewals of registrations and amendments will commence from 1st January, 2017. The final submission for renewal of the drug must contain a letter stating that entire procedure is same as before and that no new change has been incorporated after the approval of the drugs.

As stated by H.E. Dr. 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, this implementation is focused to audit and archive a wide range of medicines distributed among several multinational companies within UAE by synchronizing the information from servers of Ministry’s IT division. The database of drug registration has already been set up by the Ministry. The Ministry will conduct several workshops and seminars to help companies understand the eCTD implementation lifecycle to streamline the entire process. It is essential that all the pharmaceutical companies in UAE understand the concept of global electronic revolution and its implementation to avoid any gaps during the transformation.

In Conclusion

Major cities of UAE like Dubai, which has the highest per-capita medicine expenditure in the Middle East, is a big opportunity pool for pharmaceutical companies to explore new business perspectives. UAE is taking a big step for harmonization of regulatory submission documents by implementing eCTD. It is evident that the beginners will come across lot of challenges in understanding and execution of the concept. How exactly should companies go about this? What are the factors to be considered before, during and after implementation to avoid any product recalls? Such questions can be best taken care of by an eCTD submission service provider, offering successful submissions with zero errors in first time. The concept is new and deadlines are set, therefore staying ahead of challenges is necessary for companies for effectively meeting regulatory approvals, while efficiently employing eCTD formats.

 

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