Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Pharmaceutical Medicine Pub Date : 2022-08-01 Epub Date: 2022-06-29 DOI:10.1007/s40290-022-00432-0
Hajed M Hashan, Sarah K Al-Muteb, Ibrahim A Alismail, Othman N Alsaleh, Zakiya M Alkherb, Neil McAuslane, Stuart R Walker
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引用次数: 1

Abstract

Background: 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.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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海湾合作委员会集中监管审查程序的绩效评估:提高产品授权效率和质量的策略。
背景:海湾药品注册中央委员会(GCC-DR)作为海湾卫生委员会(GHC)的一部分,使海湾合作委员会所有成员国的药品统一注册成为可能。目的:本研究的目的是提供GCC-DR集中程序性能的更新;评估2015年1月至2020年12月期间提交给GCC集中注册的新产品的审查时间;评估采用便利的管制途径和实施依赖战略的影响;确定集中审查程序的优点和缺点;并提出可以加强海湾合作委员会监管审查程序的战略,从而改善患者获得药物的机会。方法:标准化数据收集模板使海湾合作委员会国家卫生部长理事会执行委员会高级法规事务和法规事务专家收集的信息能够结构化地形成文件,以确定GHC的结构、资源、审查模式以及里程碑和时间表。已批准的申请总数以及2015年1月至2020年12月新原料药和仿制药的平均年度时间表,包括机构的科学评估时间以及申请人对所提出问题的回应时间。每个产品的实际审批时间从提交日期到批准日期计算。结果:2019年获批新产品最少(58个),2020年最多(200个)。2015年新药的平均审评时间最长(838个日历日),2019年最短(321个日历日)。最近实施的重要变化包括增加GCC- dr会议的次数,采用标准化的电子通用技术文件和GCC监管审查模板,消除对定价协议的授权依赖以及引入依赖策略。其他建议包括执行委员会对档案审查的授权、档案验证的目标时间、科学审查和专家委员会的建议以及质量决策的培训。结论:海合会程序和决策过程受到各种专家审稿人、统一准则和信赖战略的实施的积极影响。为了提高审评的质量,在不损害审评的科学可靠性的前提下缩短监管审评时间,还必须克服某些障碍。
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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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