The Ministry of Health and Prevention (MoHAP) has advised international pharmaceutical companies to apply for marketing approval for their products in the UAE before being approved in the country they manufacture the products.
According to the ministerial resolution taken during the annual meeting of the Board of Trustees of the pharmaceutical sector in the UAE, local factories can start manufacturing procedures and apply for marketing approval for similar products during the two years preceding the end of the protection period for the innovative product.
The meeting discussed the ministerial decision on the use of information and data for innovative pharmaceutical products, which grants innovative medicines protection for its data for eight years. Such a decision would contribute to attracting unique medicines to the country, improving the healthcare sector with curative and preventive treatments that serve the interests of patients, and support medical tourism.
“This allows pre-study of the file to issue the marketing approval in the UAE for innovative products and rare medicines once they are approved by one of the reference authorities, as was the case with the GSK’s Sotrovimab drug for the treatment of some cases of COVID-19, and Amgen’s LUMAKRAS for the treatment of advanced lung cancer.”
The meeting, attended by representatives from the Ministry of Health, local and international pharmaceutical companies, local distributors, private pharmacies, and drug policy experts, also discussed ways to improve joint efforts to centralize the pharmaceutical sector’s capabilities and support national pharmaceutical industries.
The participants also discussed how to encourage innovation and investments in the pharmaceutical sector to ensure the continued growth and development of the pharmaceutical market as well as the safety of medicines in the country, and also how to improve pharmaceutical policies and legislation, including developing executive plans for regulating the distribution of pharmaceutical products to ensure public health protection.
MoHAP confirmed its commitment to responsible development and improvement of the pharmaceutical sector in order to address the present health crisis and strengthening the strategic partnership between international drug companies and local factories.