UAE Adopts Abridged Reviews For Faster Drug Approvals
Executive Summary
The United Arab Emirates has published a new decree setting out procedures for accelerated reviews of innovative and orphan medicines, creating a new standard for the rest of the gulf region.
The United Arab Emirates has codified procedures for speeding up the approval of innovative and orphan drugs by conducting abridged reviews that rely on authorizations from one of several key international regulatory agencies. The move is “good for patients and enhances the UAE’s competitiveness in the innovative biopharma sector,” according to Jeffrey Kemprecos, MSD’s executive director of public policy & government affairs in the Gulf region.
Ministerial Decree 28 of 2018 codifies the procedures for innovative and orphan products undergoing abridged regulatory review in the United Arab Emirates. “This is a significant advance that sets a new standard in the Gulf region,” Kemprecos told the Pink Sheet.
According to Kemprecos, the UAE had recently been among the fastest markets in the world to approve new medicines. In recent years, this began to change as timelines started to slip and companies reported that they were waiting longer for marketing authorization, he said. However, he is optimistic that the new decree will restore swifter approval times by setting out timelines and dates for each stage of the process. “This makes everyone more accountable,” Kemprecos added.
Under the new system, it should take between 30 and 60 working days to approve a new medicine, which “sets up the UAE to maintain its reputation ranking among the first countries in the world to approve promising new medicines,” he said.
“This is a significant advance that sets a new standard in the Gulf region” – Jefferey Kemprecos, MSD
According to the decree, a product is eligible for the abridged procedure following its approval by one of several medicines regulatory agencies: the European Medicines Agency, the US Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency/Ministry of Health, Health Canada, the Swiss Agency for Therapeutic Goods (Swissmedic), the UK’s Medicines and Healthcare products Regulatory Agency and the Therapeutic Goods Administration in Australia.
Registration files must include a letter detailing positive feedback issued by one of these agencies and the certificate of pharmaceutical product must be submitted at a later date, says the decree.
The decree, published in January, signals a “dawning awareness” in the region that regulatory systems play an import role in making a market more globally competitive and attractive to international investors, said Kemprecos. “Companies can’t commercialise a medicine if they don’t have a licence, and they can’t manufacture the product or export it without a license. Recent international policy research shows that companies are hesitant to invest in countries with unpredictable regulatory systems,” he said.
So far, Saudi Arabia, Jordan and Egypt have also implemented or announced abridged review systems.
From the editors of Scrip Regulatory Affairs.