First founded in 2019 as a new regulatory body independent from Egypt’s Ministry of Health, the Egyptian Drug Authority (EDA) has made significant progress over the last three years. Now recognised as one of the MEA region’s leading regulators, the EDA can point to several notable successes in Egypt’s battle against the COVID-19 pandemic.
Restructured & Refreshed
With healthcare now higher on the Egyptian governmental agenda than ever before, a sizeable part of the EDA’s remit is to improve the framework conditions for bringing medical innovations into Egypt, as well as producing them in-country.
To this end, the EDA now offers flexible regulations for licensing new drugs, fast track approval of new products, emergency use approval for biological products and medicines (as seen during COVID), low-cost electricity and water for operating facilities, tax exemptions for new facilities as well as production requirements and raw materials, financial and business assistance to local manufacturers, special licenses for foreign investments, and fast access to building permits and operating licenses of new factories and research centres.
Industry stakeholders are broadly appreciative of the changes underway. “We are finding the new leadership team within EDA to be forward-thinking, flexible and very open to enacting accelerated pathways for original therapies and cutting-edge innovation,” states AbbVie’s Ali Sleiman.
Ipsen’s Khaled Elrefae adds that the EDA’s adoption of a fast-track regulatory mechanism for new drugs already approved by the FDA in the United States or the EMA across Europe is “a real gamechanger.” He adds that “it moves the dial by dovetailing on the decisions of other world-renowned regulatory authorities.”
A Regional First
This speed was most clearly evidenced during the COVID-19 pandemic, when – among other successes – Egypt became the first country in Africa and the Middle East and the fourth worldwide to provide the COVID-19 antiviral Molnupiravir to its population back in January 2022, piggybacking on the drug’s FDA and EMA approvals.
EDA Chairman Tamer Essam noted that Molnupiravir – the first oral capsule to treat simple and moderate COVID cases – helps reduce the odds of hospitalisation by 50 percent. He also added that the EDA had succeeded in shortening the time period for licensing the drug for emergency use to eight months by increasing working times and better extrapolating global clinical trial data.
Maturity Level 3
The EDA’s progress has gained global recognition from the World Health Organisation (WHO), which in April 2022 designated the Egyptian authority as ‘Maturity Level 3’ in vaccine production. The WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ — an evaluation tool that checks regulatory functions against a set of more than 260 indicators, covering core regulatory functions such as product authorisation, testing of products, market surveillance, and the ability to detect adverse events — to establish their level of maturity and functionality.
Egypt did not witness any drug shortages during the worst of the pandemic and was able to coordinate vaccine manufacturing to combat the spread of the pandemic within the country.
Essam pointed out that Egypt is the first country in the Middle East to obtain this designation, asserting that it would contribute to attracting more investments to the Egyptian drug market and broaden Egyptian vaccines’ export potential. Back in January, Essam asserted that Egypt’s exports of medicines had unprecedentedly risen by 35 percent.
