A RETROSPECTIVE APPROACH ON COMPILATION OF DOSSIER FOR OMAN AS PER GCC REGULATION

Dr. J. Balasubramanian*, A. P. Chandran, Dr. Saba Maanvizhi and A. Anieshkumar

ABSTRACT

A Retrospective approach on compilation of dossier for Oman as per GCC is a stringent regulatory procedure meets the ICH standards. The Objective of the review is current trend and regulatory updates in GCC to get the Marketing authorization. The GCC is comprising of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE with two different categorizations of Centralized and De-centralized procedure as per country specific. The current review on dossier compilation of Pharmaceutical product towards GCC market comprising of administrative data, Quality, Quality overall summary, clinical and non-clinical information. In Pharmaceutical registration the dossier meets the CTD and e-CTD standards and structured to meet the regulatory requirements for a successful marketing authorization as per GCC. The current review clearly states the trends in GCC approval, procedures, Types of review, Organization structure of GCC and Drug registration procedures. Further the review clearly explains registration requirements, review process, assessments as per GCC. Additionally, a defined Oman registration procedure is highlighted as an example.

Keywords: GCC, CTD, eCTD, dossier registration, drug product, approval procedures.