The organisational framework within which the GCC-DR operates is illustrated below:

The Council of Ministers of Health (CMH), which is the highest level of authority in the organisational framework, meets twice a year, and oversees approval of all guidelines and policies adopted by the GCC-DR Steering Committee. The CMH consists of Health Ministers from each of the Gulf Cooperation Council Member States including Yemen. The CMH holds biannually two to three-day meetings, which WHO (EMRO - Regional Office for the Eastern Mediterranean) attends as an Observer. The CMH meetings are open to all regulators from the GCC States and Yemen.

The GCC-DR Steering Committee is responsible for the selection and prioritisation of topics, the assignment of guideline drafting to working groups, and the subsequent review and approval of the resulting draft guidelines. The Steering Committee is composed of 2 members from each of the Member States, including Yemen. The Executive Office for Health Ministers also appoints 2 of its affiliates as advisors (and non-voting members) to the Committee. The Steering Committee holds a minimum of four meetings per year, with committee membership limited to government agencies or drug regulatory authorities.

The process of guideline development currently involves the Steering Committee assigning the drafting of a specific guideline to either a single Member State or several Member States. Technical working group membership is at the discretion of the Member State(s) which has(ve) been assigned the responsibility of drafting a guideline, and may include regulatory, industry and academic experts.

Technical working groups have at least four 3-day meetings a year, which occur independently of the Steering Committee meetings. A fifth meeting is held with both the Steering Committee, and relevant invited experts, to discuss policy and regulations.

Once developed, the draft guideline is published on the website and comments are solicited via e-mail. Comments may also be directly invited from the relevant stakeholders (e.g. industry, wholesale agents etc.).

The GCC-DR Secretariat is permanent, and is dedicated to facilitating the activities of the harmonisation initiative through administration, coordination and communication. The secretariat is also responsible for receiving and reviewing registration files for completeness, and for preparing the agenda of Steering Committee meetings.