Gulf Health Council, Riyadh, Saudi Arabia.
Centre for Innovation in Regulatory Science, 160 Blackfriars Road, London, SE1 8EZ, UK.
Pharmaceut Med. 2022 Aug;36(4):223-231. doi: 10.1007/s40290-022-00432-0. Epub 2022 Jun 29.
The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of the Gulf Cooperation Council.
The objectives of this study were to provide an update of the performance of the GCC-DR centralised procedure; evaluate the review times for new products submitted to the GCC Centralised Registration between January 2015 and December 2020; assess the impact of applying facilitated regulatory pathways and implementing a reliance strategy; identify the strengths and weaknesses of the centralised review process; and propose strategies that could enhance the GCC regulatory review process leading to improved access to medicines for patients.
A standardised data collection template enabled the structured documentation of information collected by the Senior Regulatory Affairs and Regulatory Affairs Specialists from the Executive Board of the Health Ministers Council for GCC States to determine the GHC structure, resources, review models and milestones and timelines. The total number of applications approved was provided together with the average yearly timelines for new active substances and generics from January 2015 to December 2020 including both scientific assessment time from the agency as well as applicant response time to questions raised. Actual approval times for each product were calculated from the date of submission to the date of approval.
The fewest (58) new products were approved in 2019 and the most (200) in 2020. The average review times for new medicines were the longest (838 calendar days) in 2015 and the shortest (321 calendar days) in 2019. Important changes recently implemented include an increase in the number of GCC-DR meetings, adoption of a standardised electronic common technical document and GCC regulatory review template, removal of authorisation dependence on pricing agreements and introduction of a reliance strategy. Additional recommendations include Executive Committee mandates for dossier review, target times for dossier validation, scientific review and Expert Committee recommendation and training for quality decision making.
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.
作为海湾卫生理事会（GHC）的一部分，海湾中央药物注册委员会（GCC-DR）使海湾合作委员会成员国的药品能够进行集中注册。
本研究旨在提供海湾中央程序执行情况的最新信息；评估 2015 年 1 月至 2020 年 12 月期间提交给海湾中央登记处的新产品的审查时间；评估应用简化监管途径和实施依赖策略的影响；确定集中审查过程的优势和劣势；并提出能够增强海湾监管审查流程的策略，从而改善患者获得药物的机会。
标准化数据收集模板使高级监管事务和监管事务专家从海湾合作委员会成员国卫生部长理事会执行委员会收集的信息得以结构化记录，以确定 GHC 结构、资源、审查模式和里程碑以及时间安排。提供了批准的总申请数量，以及 2015 年至 2020 年 12 月期间新活性物质和仿制药的平均年度时间安排，包括机构的科学评估时间以及申请人对提出的问题的回复时间。从提交日期到批准日期计算每个产品的实际批准时间。
2019 年批准的新产品数量最少（58 个），2020 年最多（200 个）。新药品的平均审查时间最长（2015 年 838 个日历日），最短（2019 年 321 个日历日）。最近实施的重要变化包括增加 GCC-DR 会议次数、采用标准化电子通用技术文件和海湾监管审查模板、取消对定价协议授权的依赖以及引入依赖策略。其他建议包括执行委员会对文件审查的授权、文件验证、科学审查和专家委员会建议的目标时间以及质量决策培训。
各种专家评审员、统一的指导方针以及依赖策略的实施，对 GCC 程序和决策过程产生了积极影响。为了提高审查质量并缩短监管审查时间，而又不影响审查的科学稳健性，仍需克服某些障碍。
