The Gulf Central Committee for Drug Registration (GCC-DR) is the route through which a pharmaceutical product can be registered across the Gulf Cooperation Council states in a single procedure. This article explains how the centralised procedure works and how it relates to national registration in the UAE and Saudi Arabia.
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Who runs central registration
The Gulf Health Council describes central drug registration as a unified GCC system meant to confirm the quality, effectiveness and safety of a medicine and the accuracy of its information. The committee that carries it out was approved under Resolution No. 6 at the forty-fifth conference, held in Geneva in May 1998. GCC-DR sits within the Gulf Health Council, which a peer-reviewed evaluation describes as an autonomous agency independent of the health ministries.
How the centralised procedure works
- The applicant files a registration application for each manufacturing site that is not already accredited by GCC-DR.
- Once the Central Committee approves the site and the product, registration is finalised nationally, including pricing and issue of the registration certificate.
- Centrally approved products and accredited manufacturing sites can take part in the Gulf Group Purchasing tender.
- Post-marketing reports for centrally registered products follow the GCC-DR post-marketing surveillance guidelines; see pharmacovigilance obligations in the GCC.
Pricing and renewal
The Gulf Health Council states that the prices of centrally and nationally registered medicines are unified when they are re-registered, which takes place every five years. See GCC pricing and market access strategy.
Central or national registration
Saudi Arabia also runs its own pathways. For products already approved by reference agencies, see SFDA Verification and Abridged pathways. For devices, see medical device registration in the GCC.
How HERMS supports
HERMS Consultancy DMCC, Dubai, supports healthcare and life sciences organisations across the product lifecycle, from regulatory and market access to marketing, supply, pharmacovigilance, compliance and quality. Contact HERMS.