GCC-DR structure, registration process and points to consider when choosing this route to registration
The Gulf Central Committee for Drug Registration (GCC-DR) was formed in May 1999 with six Middle Eastern States – Saudi Arabia, Kuwait, Qatar, Bahrain, Oman and the United Arab Emirates; and in 2003 Yemen became the seventh member of the GCC-DR. The aim of the GCC-DR is to work together to review/approve pharmaceutical companies and their drugs by means of a centralised registration procedure in order to provide the seven member states with safe and effective medicines with a reasonable price. Included in the structure of the GCC-DR is a permanent Secretariat with responsibilities including the receiving/reviewing of registration files for completeness, 2 members nominated from each State regulatory authority (collectively called the “Steering committee”) with duties including company/product registration and guideline approval, a general director, an executive board, and at the highest level the Council of Ministers of Health (CMH). The CMH consists of health ministers from each of the seven member States and overseas approval of all guidelines and policies adopted by the Steering committee.