Minister of Health & Prevention issues ministerial decree for the registration of innovative medicines & orphan drugs
UAE, January 24, 2018 - The Minister of Health & Prevention H.E. AbdulRahman bin Mohammed Al Owais has issued the Ministerial Decree No. (28) of 2018 which details the mechanism for registering breakthrough and rare medicines after having obtained final approval from one of the accredited international regulatory authorities, pricing terms and obligations of the marketing authorization holder and importer of the medicines. The decree is in line with the Ministry's strategy to provide a legislative framework, regulatory and supervisory services for the health sector by creating health legislations in line with UAE Vision 2021.
H.E. Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing of the Ministry of Health and Prevention (MOHAP) and Vice Chairman of the Higher Committee for Drug Pricing and Registration the importance of the Minister’s decree noted the importance of the Minister’s decree in providing treatment options to patients in the UAE. The decision was issued after consultations with the private medical and pharmaceutical organizations, as they are strategic partners in ensuring that pharmaceutical requirements are met in line with the country’s sustainable development agenda, with the goal of enhancing the competitiveness of the medical and pharmaceutical sectors in line with global best practices.
The Ministry organizes medical registration and prioritizes to innovative and orphan medicines
He underscored that MOHAP continues to make efforts in developing the pharmaceutical sector and is committed to making treatments available to patients by prioritizing the delivery, evaluation and registration of breakthrough medicines and orphan drugs. The Assistant Undersecretary further highlighted the significance of regulating the pharmaceutical sector to ensure the quality and safety of medicines through the systematic process of registration of pharmaceutical products, control of their prices, conducting the required testing and analysis in the quality control laboratory of the ministry, as well as protecting the intellectual property of breakthrough and rare medicines.
UAE is among global leaders in the registration of medicines
Al Amiri added that the UAE is one of the leading countries globally in the process of medicines registration and the country follows the highest standards in line with the best international practices, stating that majority of breakthrough medicines are registered in the country in concurrence with the medicines’ country of origin. This reflects the interest of innovative international companies to put their medicines in the country first or second in the world after receiving accreditation from leading regulatory bodies such as the US Food and Drug Administration and the European Medicines Authority, and this reflects the trust of the international pharmaceutical industry in advanced regulations and standards applied in the UAE. He emphasized that MOHAP applies the highest international standards in the process of evaluation of drugs, which include review of clinical, bioequivalence and stability studies.
Rapid development in pharmaceutical sector
Dr. Al-Amiri said that in 2016, the value of the pharmaceutical market in the UAE amounted to AED 9.61 billion. In 2020, spending on medicine is expected to reach AED 13.13 billion and will continue to rise to AED 21.74 billion by 2025, driven by population growth, changing lifespan and the use of modern medicines such as biotechnology drugs.
Al Amiri also emphasized that there are 18 pharmaceutical facilities in the UAE and the number is expected to reach up to 34 by 2021. There are also 54 scientific offices representing international pharmaceutical companies and is expected to reach 75 by 2021 and investments from this sector have touched AED 2 billion annually. This is a strong indicator of the flourishing pharmaceutical industry in the UAE, which supports the country's efforts in global competitiveness indicators in the pharmaceutical economy.
Drug registration system subject to strict standards
He explained the process of registration of an innovative medicine, where the applicant is given an appointment for submission within a 5 working days. The application can be fast-tracked if it is submitted through electronic channels where the registration file is accepted as e-CTD. The registration files (safety + quality + pricing) submitted to the Ministry are evaluated by the Medical Registration Committee by e-mail within a period not exceeding 15 working days.
The price of the product is then guided by the price in the country of origin, as well as the price in the Gulf countries according to the pricing system implemented in the country. Decision of the registration committee will be taken and communicated electronically within 10 working days from the date of evaluation of the file. After registration of the product has been approved by majority of the members, the relevant department shall prepare the draft ministerial decree for the price approved by the Higher Registration Committee and shall submit it to the Minister or his authorized representative for approval. Finally, the registration and pricing certificate for the pharmaceutical product is issued within 48 hours from the date of the ministerial decision on the price.
Fast tracked drug registration
He pointed out that the registration of drugs that are given the status of breakthrough orphan drugs, or were placed on fast track process by the relevant authority before the final approval of the international regulatory bodies. Registration can be included in the Fast Track system of the Ministry of Health and Prevention following positive opinion issued by one of the accredited international regulatory bodies, and provided that the certificate of pharmaceutical product (CPP) will be delivered later. The price of the product shall be based on the price proposed by the marketing authorization holder or importer if the price in the country of origin is temporarily unavailable. For the product to be registered, it should have the approval from the majority of the members of the Drug Registration Committee.
In case of declined application, the registration may be presented again to the members of the Drug Registration Committee once more information about the product are provided or after approval by one of the accredited international bodies. The product is then re-priced in reference to the price in the country of origin or the prices in the GCC countries during the first year of registration. the marketing authorization holder has to submit the pricing documents within three months from the issuance of the price in the country of origin or the GCC.
Obligations of the marketing authorization holder and importer
The marketing authorization holder shall provide the packaging and insert leaflet as per the design approved by the registration committee and should implement the Pharmacovigilance, safety and risk management plan and should be alert to monitor any adverse effect of the drug that are related to specific customs followed by the patient. The importer should be committed to importing the country of origin pack after review of the insert leaflet and its approval by the Higher Registration Committee. The distributor is also responsible to set up temperature monitoring on cold chain medicines as well as provide the special analysis requirements for the Laboratory of Quality Control of Medical and Health Products of the Ministry.
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