- Discussion on the registration of 94 pharmaceutical products (including 15 innovative products, 14 biological preparations and 65 generic medicines)
UAE, Dubai: The Ministry of Health and Prevention (MoHAP) revealed that a specialized team from the Higher Committee for Drug Registration representing all UAE health authorities, has evaluated an innovative genetic drug for treating blindness resulting from hereditary retinal degeneration. The genetic drug has already been approved and registered.
This announcement came during the periodic meeting of the Drug Registration Committee, its companies and its pricing No. 137/19, which was held under the chairmanship of Dr. Mohamed Salim Al Olama, Under-Secretary of the Ministry and Vice Chairman of the Higher Committee for Drug Pricing and Registration and His Excellency Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing. Present at the meeting were also representatives of MOHAP Drug Department and local health authorities.
Committee’s Agenda
The meeting discussed the technical committee outcomes for registering innovative, biological and similar medicines manufactured locally or internationally.
The total number of those medicines was 94 pharmaceutical products, including 15 innovative products, 14 biological preparations, and 65 generic medicines, in addition to discussing the pricing of 213 drugs among other topics
Drug Registration Committee reviewed various applications of international pharmaceutical companies. The main criteria for examining these applications are its positive contribution to the treatment of various diseases in the country.
While considering these applications, the committee takes also into account the economics of companies and supporting their activities that contribute to the ministry's efforts in developing the drug sector and providing treatment to patients as soon as possible, by prioritizing the rapid receipt and evaluation of this product category.
Medical Registration Standards and Regulations
Al-Amiri affirmed that the UAE took precedence over the registration of medicines in accordance with the standards and regulations that conform to the best international practices. He pointed out that most innovative medicines are registered in the country in conjunction with the innovative countries of these medicines.
Al Amiri also stressed the importance of the Ministry's supervision of the pharmaceutical sector, quality and safety of drugs in the UAE, through pharmaceutical registration, drug price adjustments, in addition to conducting the necessary tests of pharmaceutical products in the reference laboratory, as well as, following up on the safety of use in the country through drug vigilance programs.
Adopting a Global Mechanism for Drug Registration
With regards to the evaluation of the pharmaceutical product, Al Amiri explained that MoHAP depends on the clinical studies implemented in most countries of the world.
“Developing a new pharmaceutical product usually takes 10 years including laboratory studies, the new product is then tested to check interaction of pharmaceutical compounds with the living organisms and assure their pharmacological movement in terms of absorption, metabolism processes and methods of its excretion. The aim of these tests is to evaluate the side effects and toxicity expected, as well as to determine the effective therapeutic dose, as well as the lower, higher and toxic doses. The drug is then tested on patients according to a controlled clinical plan, then to be submitted to the global bodies to evaluate all studies and to approve its use and put it on the market,” Al Amiri said.
It is worth mentioning that UAE is one of the world’s first countries to obtain this drug. This reflects the keenness of the innovative global companies to launch its medicines in the UAE as the world’s first or second country, after being approved by international bodies such as the FDA and EMEA. This also reflects the confidence of those companies in the country's advanced regulations and standards in the pharmaceutical and medical fields and its quick medical registration system.
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