Evaluation of good review practices at the Food and Drugs Authority of Ghana as it strives to become a World Health Organization-listed agency

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology Pub Date : 2025-08-29 DOI:10.1016/j.yrtph.2025.105932

Mercy Owusu-Asante , Delese Mimi Darko , Seth Seaneke , Neil McAuslane , Stuart Walker , Sam Salek

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引用次数: 0

Abstract

The aim of this study was to assess the good review practices (GRevPs) of the Food and Drugs Authority (FDA) Ghana in order to identify opportunities for improvement.

Reviewers of the FDA Ghana completed an established, structured and multi-dimensional questionnaire for the assessment of GRevPs. Twenty-seven of 30 assessors took part in the study; 70 % reported that GRevPs have been implemented and fully adopted across the authority. The three most common reasons quality measures were implemented at FDA Ghana were to be more efficient, ensure consistency, and to minimize errors. Most respondents believed that the current GRevPs framework could be improved and additional training to learn and understand how GRevPs are to be used and incorporated into daily work; 90 % reported that the FDA Ghana has a consistent method for documenting GRevPs that need improvement and a mechanism to facilitate updating. In general, the importance of GRevPs was well understood by the assessors; however, target timelines were not well followed at both the department and agency levels. This study provided a baseline for the FDA Ghana GRevP knowledge, attitudes, and practices as well as areas for improvement to work toward becoming a World Health Organization-listed authority.

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在加纳食品和药物管理局努力成为世界卫生组织上市机构的过程中，对其良好审查做法进行评估。

本研究的目的是评估加纳食品和药物管理局（FDA）的良好审查规范（GRevPs），以确定改进的机会。FDA加纳审查员完成了一份既定的、结构化的、多维度的问卷，用于评估grevp。30名评估员中有27人参加了这项研究；70%的人报告说，grevp已经在整个机构实施并完全采用。在FDA加纳实施质量措施的三个最常见的原因是更有效，确保一致性，并尽量减少错误。大多数受访者认为，目前的grevp框架可以得到改进，并进行额外的培训，以学习和了解如何使用grevp并将其纳入日常工作；90%的人报告说，FDA加纳有一个一致的方法来记录需要改进的grevp，并有一个促进更新的机制。总的来说，评估人员很好地理解了grevp的重要性；但是，在部门和机构一级都没有很好地遵守目标时间表。本研究为FDA加纳GRevP的知识、态度和实践以及改进领域提供了基线，以努力成为世界卫生组织上市的权威机构。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Regulatory Toxicology and Pharmacology 医学-毒理学

CiteScore

6.70

自引率

8.80%

发文量

147

审稿时长

58 days

期刊介绍： Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)