Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality.
Hajed M HashanSarah K Al-MutebIbrahim A AlismailOthman N AlsalehZakiya M AlkherbNeil McAuslaneStuart R WalkerPublished in: Pharmaceutical medicine (2022)
GCC procedures and decision-making processes have been positively influenced by a variety of expert reviewers, unified guidelines and the implementation of a reliance strategy. Certain barriers must still be overcome to enhance the quality of the review, and to shorten regulatory review times without compromising the scientific robustness of the review.