Innovative drugs must be registered in five days

Dubai: Innovative drugs approved by accredited international regulators must be registered in the UAE within five working days, according to a ministerial decree issued by the Ministry of Health and Prevention.

The price of the product must be guided by its price in the country of origin and the price proposed by the marketing authorisation holder or importer. The importer will also be responsible for providing packaging and leaflets for insertion as per the design approved by the registration committee. The distributor is also responsible for setting up temperature monitoring on cold chain medicines as well as providing special analysis requirements for the Laboratory of Quality Control of Medical and Health Products of the ministry.

Drugs that are declined can be presented again for registration, Dr Amin Hussain Al Amiri, assistant undersecretary for Public Health Policy and Licensing at the ministry and vice-chairman of the Higher Committee for Drug Pricing and Registration, said.

Dr Al Amiri 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.

Dr Al Amiri said : “In 2016, the value of the pharmaceutical market in the UAE amounted to Dh9.61 billion. In 2020, spending on medicine is expected to reach Dh13.13 billion and will continue to rise to Dh21.74 billion by 2025, driven by population growth, changing lifespan and the use of modern medicines such as biotechnology drugs.”

He also added that at present UAE has 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 Dh2 billion annually.” he said.


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