Snapshot

The GHC Central Registration pathway has been developed by the Gulf Health Council of GHC-GCC.

This pathway can be used where Pharmaceutical Products (Any Medicine Manufactured on Pharmaceutical Basis)..

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Bahrain Kuwait Oman Qatar Saudi Arabia United Arab Emirates Yemen

When relevant, the agency relies on prior decisions from EU-EMA GHC-GCC United States WHO

12 months at the GCC level and then 3 months maximum at the national level. Note: In July 2020, GHC published a circular indicating that a reliance model can be applied for products approved in at least 2 GCC countries. In this case, GHC centrally approves the product within 60 calendar days from submitting the scientific reports issued by the GCC countries. Validation of marketing authorisation applications consists of a verification of legal, good manufacturing processes, patent and intellectual property status, confirmation of an acceptable format and content of the application and payment of fees. Queueing for the scientific assessment can take 60–180 calendar days, although priority products may be taken out of the queue to be the subject of an expedited review. All member states receive dossier files and have the option to review, but two member states are specifically named by the Expert Committee to review the files for quality, safety and efficacy in parallel and provide their recommendations to the GCC-DR. The Expert Committee provides a peer review of the dossier and issues its recommendation, which the GHC is mandated to follow. However, authorisation does not depend on pricing agreements. There are no target times for validation, scientific assessment, or Expert Committee evaluation, but there is an overall review target time of 365 days for a full review and 120 days for priority review and this includes both agency and manufacturer’s response time. The GCC-DR conducts type 3A reviews for all major applications (NASs and major line extensions). A priority review track is in place for vaccines and anti-carcinogenic therapies. However, if a product has been approved by two Gulf States or by the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA) or the WHO prequalification (as reference agencies) then the GCC-DR will conduct an abridged review. If a product is registered in all member states, then the GHC will conduct a verification review, which is normally achieved within 21 days.