An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States

作者：Al Essa Reem; Salek Sam^*; Walker Stuart

来源：Drug Information Journal, 2012, 46(1): 57-64.

DOI：10.1177/0092861511427110

• good review practice
• regulatory review
• quality measures
• assessment templates

The aim of this study was to evaluate how each Gulf Cooperation Council (GCC) regulatory authority is building quality into the assessment and registration process and to establish opportunities for the exchange of best practice between the GCC states. A questionnaire was completed by the 7 Gulf States (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates [UAE], and Yemen), which provided details of the quality attributes that characterize the extent of the scientific assessment in the region. The results showed that each authority has its unique practices that characterize their 7 milestones in comparison with the other GCC authorities. Bahrain uses good review practice (GRP) guidelines and has placement arrangements in competent authorities, while Kuwait has separate pricing and registration departments. Oman engages external audit programs from accredited bodies, while Saudi Arabia and UAE conduct formal training for their assessors.

• 出版日期2012-1