DUBAI: International pharmaceutical companies have been asked by the UAE to apply for marketing approval of their products in the emirates before being approved in the country of manufacture.
This will allow health authorities a 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 reference authorities.
Such an approval was made by the Ministry of Health and Prevention (MoHAP) in the case of GSK’s Sotrovimab drug for the treatment of some cases of Covid-19 and Amgen’s LUMAKRAS for the treatment of advanced lung cancer in May and June this year, said Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing, and Chairperson of the Pharmaceutical Board of Trustees.
A MoHAP press release said factories in UAE 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, Al Amiri told a meeting of the Board of Trustees.
Local manufacturers can grab this opportunity and market their products in the UAE soon after the expiry of the protection period for innovative products.
Also discussed was MoHAP’s decision granting innovative medicines protection for its data for eight years. Such a decision would contribute to attracting innovative medicines to the country, enhancing the healthcare sector with curative and preventive solutions that serve the interests of patients, and support medical tourism, the press release said.