ABU DHABI, 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 manufacturing country, according to a senior official.
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, said Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing, and Chairperson of the Pharmaceutical Board of trustees.
He was presiding over the annual meeting of the Board of Trustees of the pharmaceutical sector in the UAE, via video conference, said a MoHAP press release on Monday.
According to the ministerial resolution, 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, Al Amiri noted.
Al Amiri called on local factories to tap into this opportunity to market their products in the country as soon as the protection period for innovative product ends. He also highlighted the exceptions set forth in the resolution, such as emergency situations and cases in which the right holder to market an innovative product has given his approval to manufacture a similar 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 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 ministry is keen to enhance cooperation and improve productivity in the field of medicine and medical supplies, and to continue strengthening the attractiveness of legislative and investment environment, thanks to the facilities and privileges enjoyed by the industry in the country, which pave the way for establishing more competitive medical industries, pointed out Al Amiri.
Attended by representatives of the health authorities, local and international pharmaceutical companies, local distributors, private pharmacies, and drug policy experts at the Ministry, the meeting also discussed means of enhancing joint efforts to consolidate the capabilities of the pharmaceutical sector and support the national pharmaceutical industries.
The participants also looked into the means to encourage innovation and investments in the pharmaceutical sector to ensure the continued growth and development of the pharmaceutical market and the safety of medicines in the country.
The importance of coordination between the parties was also discussed, especially in relation to pharmaceutical policies and legislation, and preparing executive plans for regulating the distribution of pharmaceutical products to ensure the protection of public health.
Representatives of health authorities, local and international pharmaceutical companies, local distributors and private pharmacies stressed the importance of building a common vision and practical plans to enhance joint cooperation and support the national plans to protect community health and enable patients to obtain safe medicine.
They reaffirmed their commitment to developing and improving the pharmaceutical sector in a responsible manner to meet the current health challenge, and strengthen the strategic partnership between international drug companies and local factories, said the MoHAP press release.
Source: Emirates News Agency