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Ministry of Health and Prevention Hosts the 91st Meeting of Central Gulf Committee for Drug Registration

Healthcare Issues / 2 Apr 2019

Ministry of Health and Prevention Hosts the 91st Meeting of Central Gulf Committee for Drug Registration

Ministry of Health and Prevention Hosts the 91st Meeting of Central Gulf Committee for Drug Registration

The Ministry of Health and Prevention (MoHAP) hosted the 91st meeting of the Central Gulf Committee for Drug Registration in the Emirate of Dubai, in the presence of His Excellency Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing and members of the Central Gulf Committee for Drug Registration.

At the outset of the meeting, HE Dr. Al Amiri conveyed the greetings of His Excellency Abdulrahman Al Owais, Minister of Health and Prevention to the members of the committee.

In his opening remarks, Dr. Al Amiri tackled several essential pillars including; the focus on drug safety and the importance of providing support to the internationally approved drugs by the global drug agencies, particularly, Food and Drug Association (FDA) and European Medicines Agency (EMA).

The other pillars included raising the standards of similar medicines industry across Arab countries and worldwide, in addition to the expeditious completion of innovation and similar medicines registration between the States of the region, as well as the rapid implementation of decisions and directives issued by the Health Ministers’ Council for the GCC States.

Unifying Gulf Efforts in Drug Registration 

Dr. Al Amiri further said that GCC recent orientations aim at unifying efforts of providing support to pharmaceutical industry and encouraging local factories to focus on manufacturing innovative medicines, as well as enhancing the confidence of the society in Gulf local pharmaceutical industry.

Also, the meeting discussed the initiatives and approaches which encourage the support of pharmaceutical industry in GCC countries, as well as develop the standards and regulations fostering local and global investment in the pharmaceutical industry through a successful model represented in the UAE in this regard.

A Busy Agenda on Registration of Pharmaceutical Products and Companies

Further to that, the meeting touched on updating the list of central drug registration, as well as updating the Gulf guidance for bioequivalence studies and stability to keep pace with Who’s guides (ICH, USADA). Accordingly, the Saudi Drug & Food Authority has been assigned to update the bioequivalence guidance, as well as Oman, Kuwait and UAE to update the stability guidance considering the ICH requirements.

The meeting also tackled the Guidance for Priority Review of Product Registration including vaccines, cancer medicines, and the registered Gulf drugs in two reference countries, in addition to any other necessary topics the Director of Drug Registration sees they have to be presented to the committee. Those topics may include the participating companies in the unified procurement tenders, mechanism of registration through Verification, registration through Abridged and the mechanism followed in the member states concerning the suspension, withdrawal, and cancellation of products.

One of the meeting agenda items was the mechanism of pharmaceutical products license renewal and review of contact information of the National Pharmacovigilance Centres (NPC) in order to update the medication package insert, then circulate it on the companies according to the committee’s decision. Also, the members considered the approval of Guidance for Graphic Design of Medical Packaging and review of the E-Central Gulf Programme for Central Registration.

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