The UAE ranks as a world leader in rapid drug approvals with its fast-track registration system that accelerates the process and eliminates long waiting times for innovative and orphan drugs.
If you bring innovation, the [UAE] government will support you on all levels
Georg Schroeckenfuchs, Novartis
In January 2018 the Ministry of Health and Prevention of the United Arab Emirates (MOHAP) announced a resolution that would allow fast-track registration of innovative and orphan drugs. Innovative drugs are defined as ‘drugs that contain an entirely or partially new active ingredient and whose owner holds a patent’ and orphan drugs are defined as ‘drugs that are used for treatment, diagnosis or prevention of rare diseases.’ (Source: Mondaq.com) In the fast-track process, the so-called Drug Registration Committee evaluates an application for a new drug within 15 working days of submission and makes the decision to approve or reject the application within 10 working days from the date of evaluation.
Some recent approvals include AstraZeneca’s cancer drugs Tagrisso and Calquence, in which the UAE ranked first in the world in approval time. The Emirates ranked second for blockbuster drugs such as Merck’s Keytruda and Novartis’s Entresto.
Georg Schroeckenfuchs, Middle East president and head of the MENA Cluster at Novartis, expressed his surprise at the innovation-friendly approval process in the UAE: “When I first arrived in the UAE, I immediately noticed there was a substantial difference in comparison to Europe with regard to the innovation-friendly environment offered here. In my 32-year long career, I have never experienced an environment quite like this one. For example, the Minister of Health sent us an email stating that he had noticed Novartis was not filing for migraine medication, and the government would like to ensure their patients were one of the first countries to receive access. That was a unique experience for me as in the majority of countries it is a lengthy process, and a government’s response is normally that there is little or no need for a drug. Once we had filed for the migraine medication in the UAE, it was registered and reimbursed within six weeks. This demonstrates that if you bring innovation, the government will support you on all levels.”
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