背景:非洲药品监管协调(AMRH)倡议于2009年成立,随后,三项区域倡议(东非共同体药品监管协调[MRH],南部非洲发展共同体[南部非洲发展共同体]/ZaZiBoNaMRH,和西非国家经济共同体MRH)成立。由于这些举措是非洲药品管理局(AMA)的基础,这项研究的目的是比较他们的运营模式,成功和挑战,以确定改进和调整的机会。
方法:使用混合方法方法进行数据收集,使用问卷调查,过程,有效性和效率等级(PEER),作者专门为这项研究开发的半结构化访谈技术。有23名研究参与者(来自三个地区成员国的每个机构)。希望这项研究产生的数据将导致一系列建议,然后由监管机构批准。
结果:大多数受访者表示,AMRH有助于加强非洲经济区域的监管体系和协调监管要求,可能导致更好地获得有质量保证的药物。尽管在不同的时间和每个地区的判断下建立,营销授权申请审查流程在很大程度上相似,在资格和提交要求中注意到一些差异,所采用的程序类型,时间表和应付费用。这三个区域确定的挑战也相似,最值得注意的是缺乏具有约束力的区域批准法律框架。
结论:在这项研究中,我们比较了这个过程,这三个区域协调倡议在非洲解决法律框架领域的成功和挑战,信息管理系统,药物的可及性和可负担性以及将在其运营模式中带来更大的一致性和效率的依赖,从而加强即将运营的AMA的基础。
BACKGROUND: The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa MRH, and the Economic Community of West Africa States MRH) were established. As these initiatives serve as a foundation for the African Medicines Agency (AMA), the aim of this study was to compare their operating models, successes and challenges to identify opportunities for improvement and alignment.
METHODS: A mixed method approach was used for the data collection using a questionnaire, the Process, Effectiveness and Efficiency Rating (PEER), developed by the authors specifically for this study and semi-structured interview techniques. There were 23 study participants (one from each agency of the member countries of the three regions). It was hoped that data generated from this study would lead to a series of recommendations, which would then be ratified by the regulatory authorities.
RESULTS: Most respondents stated that AMRH contributed to the strengthening of regulatory systems and harmonising regulatory requirements across economic regions of Africa, potentially resulting in improved access to quality-assured medicines. Although established at different times and at the discretion of each region, the marketing authorisation application review processes are largely similar, with a few differences noted in the eligibility and submission requirements, type of procedures employed, the timelines and fees payable. The challenges identified in the three regions are also similar, with the most noteworthy being the lack of a binding legal framework for regional approvals.
CONCLUSIONS: In this study, we compared the process, successes and challenges of these three regional harmonisation initiatives in Africa addressing the areas of legal frameworks, information management systems, the accessibility and affordability of medicines and reliance that will bring greater alignment and efficiency in their operating models, thereby strengthening the foundation of the soon-to-be-operationalised AMA.