Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities.

IF 2 4区医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-12-27 DOI:10.1007/s43441-024-00730-6

Constance Sakala Chisha, Makomani Siyanga, Stephanie Leigh, Adem Kermad, Stuart Walker

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Abstract

Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products approved from 2020 to 2023, as well as good review and quality decision-making practices implemented in the review process.

Methods: A standardised, validated questionnaire; Optimising Efficiencies in Regulatory Agencies (OpERA) and the OpERA Data Collection Template were completed by the author.

Results: Three review models are used by ZAMRA to review new active substances (NASs) and generic products: verification, for products prequalified by the World Health Organization or approved by a stringent regulatory authority (SRA); abridged, for well-established molecules or SRA-approved products; or full, for products not otherwise prequalified. Good review practices and quality decision-making processes were followed but could be improved.

Conclusion: This study assessed the overall ZAMRA operation and identified the key milestones in the review process for products approved from 2020 to 2023, target timelines achieved and the compliance to standard good review and quality decision-making practices.

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赞比亚药品监管局监管审查程序的评估：挑战和机遇。

目的：本研究旨在通过确定2020年至2023年批准的产品的关键里程碑和目标时间表，以及在审查过程中实施的良好审查和质量决策实践，评估赞比亚药品管理局（ZAMRA）当前的监管审查过程。方法：采用标准化、有效问卷；优化监管机构的效率（OpERA）和OpERA数据收集模板由作者完成。结果：ZAMRA采用三种审评模式对新原料药（NASs）和仿制药进行审评：对经世界卫生组织预审或经严格监管机构（SRA）批准的产品进行审评；删节，用于已建立的分子或sra批准的产品；或全部，对于没有其他资格预审的产品。良好的审查做法和高质量的决策过程得到了遵循，但可以加以改进。结论：本研究评估了ZAMRA的整体运作，并确定了2020年至2023年批准的产品审查过程中的关键里程碑，目标时间表的实现以及对标准良好审查和质量决策实践的遵守情况。

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来源期刊

Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY

CiteScore

3.40

自引率

13.30%

发文量

127

期刊介绍： Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations