The pricing and registration committee of the United Arab Emirates' Ministry of Health has announced the approval of 108 drugs, pricing approval for 224 drugs, and manufacturing site authorisation for 6 facilities. In addition to these announcements, the committee has introduced stricter drug prescription requirements.
IHS Global Insight perspective | |
Significance | The United Arab Emirates' Ministry of Health has introduced tougher requirements for prescriptions, approved 108 drugs, granted pricing approval to 224 drugs, and authorised 6 manufacturing facilities. |
Implications | The announcement of the drug approvals is likely to be seen as providing the relevant manufacturers with access to the fast growing UAE market. The new prescription regulations are likely to be viewed as moving the UAE closer to prescribing guidelines seen in more regulated markets. |
Outlook | Greater regulations alongside timely drug approvals are likely to attract international pharmaceutical companies to invest in the UAE. |
The Drugs Pricing and Registration Higher Committee of the United Arab Emirates' Ministry of Health (MoH) has issued approvals for 108 drugs. These approvals cover numerous therapy areas, including oncology, diabetes, cardiovascular, inflammatory, and immunology conditions. A list of the exact molecules that were approved has not been disclosed. Further, the make-up of the list of approved drugs remains unclear; the MoH's press release suggests that of the new approvals, 136 are innovative, 169 are biologics, and 91 are generics. This contrasts with various news sources, such as UAE Interact, which suggest the new approvals include 13 innovative, 6 biologics, and 91 generics. The committee has also granted clinical trial protocol approval for two oncology drugs that it refers to as being for "the treatment of tumours". A further two oncology drugs appear to have received approval based on the conducting of post-marketing surveillance activities. Additionally, one product referred to as an "international oral eye drop" has had its product approval revoked. A copy of the department's press release detailing the approvals can be accessed here.
The MoH's Drugs Pricing and Registration Higher Committee is made up of representatives of the Abu Dhabi Health Authority, the Dubai Health Authority, the Sharjah University, and the assistant undersecretary for medical practices and licensing, Dr Amin Al Almiri.
In addition to drug approvals, the committee has also considered granting pricing approval, with 224 new drugs receiving pricing approval under new pricing regulations. The list of drugs that have received pricing approval has not been disclosed.
The committee also examines approvals for manufacturing facilities, and has granted six new licences for pharmaceutical manufacturing sites. Alongside the manufacturing approvals, the committee has taken action against manufacturing facilities, postponing one manufacturing licence application and rejecting approval for another unknown site, with the latter only being described as an "Arab site".
New prescribing system
As part of its announcement, the committee also moved to introduce stricter prescribing controls. These controls provide two classifications for prescription drugs, affecting the maximum length of prescriptions physicians can issue. Under the measures, drugs referred to as "CDA" drugs can have prescriptions lasting for up to 3 days in emergency settings, 15 days for specialist physicians, and 30 days in the case of psychiatrists and neurologists. Meanwhile, drugs referred to as "SDA" drugs can last for up to 30 days in the case of general practitioners and 30 days with an option to repeat prescriptions for specialist physicians.
Outlook and implications
The introduction of new prescribing regulations is likely to be viewed as bringing the UAE closer to international standards. Indeed, these measures appear close to standard controls seen in a number of regulated markets.
Given scarce published information regarding these drug approvals, as well as other measures, it is perhaps challenging to judge the impact of these drug approvals. Despite the uncertainties around the announcement, it is likely to be viewed as a strong positive for pharmaceutical companies, as approvals grant them access to the fast-growing UAE market.
However, despite optimism in the UAE market being driven by increasing insurance penetration and growing prevalence of lifestyle-related diseases, such as the explosion in type 2 diabetes, excitement is likely to be tempered by drug pricing reforms. These reforms brought 6,619 medicines under pricing regulations, with prices seeing anticipated cuts of up to 40% (see United Arab Emirates: 5 February 2013: UAE to introduce drug pricing scheme, cost of 6,619 medicines expected to fall by up to 40%).
The committee's most recent announcement echoes other approvals that have seen a significant number of drug approvals conducted simultaneously; before September 2010 the committee did not approve more than five products at the same time (see United States - United Kingdom - United Arab Emirates: 14 December 2010: U.A.E. Drugs Committee Approves New Products, Prices, and Manufacturing Sites; HAAD Signs Chronic Disease Agreements with Big Pharma).