批准建立非洲药品管理局条约的进程:国家监管机构的观点。

IF 2.9 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Health policy and planning Pub Date : 2024-05-15 DOI:10.1093/heapol/czae017
Bakani Mark Ncube, Admire Dube, Kim Ward
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引用次数: 0

摘要

非洲药品管理局(AMA)的愿景是确保所有非洲人都能获得负担得起的、符合国际公认的质量、安全和疗效标准的医疗产品,以治疗重点疾病/病症。非洲药品管理局是根据一项条约建立的,该条约必须得到至少 15 个非洲国家的批准。虽然没有规定最后期限,但批准进程比预期的要慢。因此,本研究分析了建立非洲医学协会的理由、预期利益、有利因素和挑战。本研究对 45 个非洲国家的国家药品监管机构 (NRA) 进行了定性、横断面普查。我们联系了国家药品监管局的负责人和一名国家药品监管局的高级工作人员,让他们填写自填问卷。成熟的国家药品监管机构的存在、建立统一监管体系的愿望、强烈的政治意愿以及为加快条约签署而进行的适当宣传都是促进非洲药品管理局条约签署的有利因素。所报告的挑战包括:进程缓慢,对进程的了解有限。所报告的挑战还包括:国家优先事项相互竞争、公共系统负责人的变动以及部级进程停滞不前。这项研究提高了非洲非驻地机构对条约签署和批准进程的认识,以及从非洲非驻地机构的角度看签署和批准条约的好处和有利因素。非驻地机构还强调了在这一过程中遇到的挑战。通过在非洲大陆层面调动技术支持、监管专业知识和资源,应对这些挑战将有助于实现有效的药品监管。
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The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies.

The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognized standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA's establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The Heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonized regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process and the perceived benefits and enabling factors of signing and ratification from African NRAs' perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanizing technical support, regulatory expertise and resources at a continental level.

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来源期刊
Health policy and planning
Health policy and planning 医学-卫生保健
CiteScore
6.00
自引率
3.10%
发文量
98
审稿时长
6 months
期刊介绍: Health Policy and Planning publishes health policy and systems research focusing on low- and middle-income countries. Our journal provides an international forum for publishing original and high-quality research that addresses questions pertinent to policy-makers, public health researchers and practitioners. Health Policy and Planning is published 10 times a year.
期刊最新文献
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