69 new drugs approved including one to treat leukaemia
Dubai - Dr. Al Amiri pointed out that the committee discussed the prices of 132 drugs and approved the re-pricing of another 14 drugs in line with patients' right to obtain secure, inexpensive and useful medicines.
The Supreme Committee for Drug Registration of the Ministry of Health and Prevention has approved the registration of 69 new drug classes based on global clearances, following the completion of various technical requirements.
Following ratification by the US Food and Drug Administration (FDA), the UAE Ministry of Health and Prevention has registered a new drug that can treat three types of leukaemia at once, notably Chronic Lymphocytic Leukaemia (CLL). CLL is a serious type of cancer that affects the blood and bone marrow and is caused by the occurrence of a genetic mutation in the DNA cells, deteriorating the patient's condition slowly over time.
The committee made the approval at a meeting at the Quality Control Laboratory located in the Dubai Biotechnology and Research Park (DuBiotech) in the presence of senior representatives from the UAE Ministry of Health and Prevention (MOHAP), Health Authority Abu Dhabi (HAAD), and the Dubai Health Authority (DHA) along with leading universities in the country.
The session was headed by Dr Amin Hussein Al Amiri, Assistant Undersecretary for Public Policy and Licensing of the Ministry of Health & Prevention and Vice-Chairman for Supreme National Drug Registration.
The committee has deferred 11 varieties of drugs for lack of probative safety of use and marketed in the reference countries, as well as rejected four varieties of medicines for non-conformity with the required quality standards. The approved drugs consist of of therapeutic medicines for treatment of blood pressure, diabetes, chronic obstructive pulmonary disease and women ailments as well as four biological drugs, including polio vaccine from a qualitative 1 & 3, and medicines for diseases such as leukaemia.
Dr. Al Amiri emphasised that the ministry only approves and registers drugs manufactured by accredited pharmaceutical companies and meet all the required international standards. He added that the ministry will conduct inspections on local, regional and international pharmaceutical companies to ensure their conformity with international safety standards as well as instructions issued by the World Health Organisation (WHO) and other international authorities such as the FDA and the European Medicines Agency. The committee has approved 11 pharmaceutical factories and delayed the approval of five others operating in Greece, Turkey and India, while two factories of an Indian company were suspended.
Dr. Al Amiri pointed out that the committee discussed the prices of 132 drugs and approved the re-pricing of another 14 drugs in line with patients' right to obtain secure, inexpensive and useful medicines.
When international pharmaceutical companies discover a new drug, they register the name and give it a brand name in addition to the scientific name of the drug. The company which discovers and produces it has the intellectual property rights to patent it, with no other firm allowed to manufacture this medicine for a certain period of time, usually 20 years. However, after the expiry of the ban, any pharmaceutical company has the right to produce the same drug, but under a different name.
Dr. Al Amiri said: "The phenomenon of using medication without any checks rules poses a serious threat to the individual and society. Note that the number of drugs that have been registered by the Ministry to date is 8,327, including 5,218 in unprecedented class and 3,109 in innovative class."