GoDubai
  
  
  
  
Citylife > Press Release
  Home Contact us Add to Favourites
Most Recent Postings
More Press Releses
Featured Sections

Event Finder
A daily roundup of exhibitions, promotions and other events in Dubai and the rest of the Emirates.
Submit an Event
Latest Dubai Press Releases >> Government, Legal and Humanity

 
  Share

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.



Posted by : GoDubai Editorial Team
Viewed 3568 times
Posted on : Wednesday, January 24, 2018  
Replication or redistribution in whole or in part is expressly prohibited without the prior written consent of GoDubai.com.
Previous Story : Ministry of Economy: ECHA sets May as final deadline for registration of chemical exporters to Europ...
Next Story : Minister of Climate Change and Environment Meets with Fishermen at Dibba Al Hisn and Al Fujairah
Email this article Print this article

Share this article with your friends and followers
NewsVine

Comments

Back to Top  
Most Viewed Press Release posted in the last 7 days
Fresh Hair in an Instant with SHOW Beauty
Amadeo® Fleurier 39 “Fan”
Mother's Day Gift Guide 2018 from The Little Birdy Group
Show/Pop-up Event “Pret-A-Cover™ Buyers Lane” to Be Launched in Dubai From March...
Moreish Café in Dubai introduces a healthy Quinoa Burrito
True Colours
Robinsons Honored for Outstanding Store Design
Splash receives 2 awards
UAE Team Emirates' Mirza Takes Gold at Asian Cycling Championships
Phenomenal development in falconry racing from small beginnings: HHC Deputy CEO
WGS 2018: Opening Session Highlights Importance of Embracing Smart Living to Enh...
RAK Hospital launches the biggest weight-loss challenge in association with MoHA...
2XL launches Malmo Bed with floral designs for a vintage shabby chic inspired ma...
Food Lovers Rejoice: Dubai Food Festival Is Back This Month
Bridal Glow is Skin Deep: Tips for every bride-to-be in 2018
Mealtop, Introducing a Whole New Dessert Experience
Optim-Eyes Lashes & Brows with Filorga
Al Ahli Holding Group to redefine the UAE value shopping category through an AED...
NEZO launches new identity to guide consumers in selecting the best salt for the...
Safilo Group Reveals Its Spring/ Summer 2018 Collection
WGS 2018: Governments Need to Prioritize Wellbeing of Citizens, Say Internationa...
Redefining the Skin Clinic Experience. #allnewkaya opens in Muscat City Centre!
The new BMW HP4 RACE arrives at Abu Dhabi Motors – one of just 750 built
The Robots Are Coming: Ministry of Finance Brings Artificial Intelligence to Dub...
Leading Scientists, Astronauts Share Insights on why Space Exploration Matters a...
Kate Spade New York Spring 2018 Collection
New Report from Accenture and the World Government Summit Finds That Regulators ...
ADNOC Schools Team Wins Etihad Artificial Intelligence Competition
Garbiñe Muguruza Hungry for Success at Dubai Duty Free Tennis Championships
First Ever UAE Race Car Fitted with Immensa 3D Printed Parts
Global Expansion in sight for ICONS© Coffee Couture
WGS 2018: Innovation to Propel Dubai into the Next Century
WGS 2018: Governments of the Future Must Work Smartly with Innovation and Technology
Catch Some Zzz's in the IKEA Nap Truck
Dubai Electronic Security Center Receives Overwhelming Interest From Regional an...
Turkish Airlines has announced its 2018 January passenger and cargo traffic results.
Global energy shifts set to transform the Middle East energy sector
Emirates firms up order for up to 36 additional A380s
Dubai Airports' new Modular Data Centre Complex (MDCC) a 'world first'
Al Ghurair Foundation for Education Event on ‘Graduating Work Ready Youth' Unvei...
Dual Investments Brand LE66 to Relocate from City Walk to New Dubai Location in 2018
WGS 2018: Global Policy Platform Panel Considers Supporting Female Entrepreneurs...
Do You Feel Sleep Deprived? Nearly Half of UAE Would Give Up Social Media for an...
WGS 2018: Renowned Innovation Expert Fast Forwards Time to Showcase Glimpse of t...
South African artisans of fine leather products look to make big impression at L...
Former Indian Space Chief Presents Country as a Global Low-Cost Provider of Sate...
WGS 2018: For the Future of Mankind, Mars is the Next Frontier, Says Renowned Ar...
15,000 participate in the Dubai Cares' annual Walk for Education 2018 in support...
Ground-breaking cellular therapy set to revolutionise treatment for children wit...
DAMAC Properties deliveries surpass 20,000 unit milestone as it reports net prof...