Sithole Tariro, Mahlangu Gugu, Walker Stuart, Salek Sam
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
Medicines Control Authority of Zimbabwe, Harare, Zimbabwe.
Front Med (Lausanne). 2022 Apr 25;9:898725. doi: 10.3389/fmed.2022.898725. eCollection 2022.
The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African Development Community ZaZiBoNa, established in 2013. A recent study was carried out with the nine active member regulatory authorities of the ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having obtained the authorities' views, the aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative including the challenges it faces as well as identifying opportunities for improvement from the applicants' perspective.
Applicants who had submitted registration/marketing authorisation applications for assessment under the ZaZiBoNa initiative during 2017-2021 were recruited into the study. Data was collected in 2021 using the Process, Effectiveness and Efficiency rating questionnaire (PEER-IND) developed by the authors. The questionnaire was completed by a representative responsible for ZaZiBoNa submissions in each company.
The pharmaceutical industry was of the view that the ZaZiBoNa initiative has achieved shorter timelines for approval of medicines, resulting in increased availability of quality-assured medicines for patients in the SADC region. Harmonisation of registration requirements and joint reviews have reduced the workload for both the pharmaceutical industry and the regulatory authorities. Some of the challenges identified were the lack of a centralised submission and tracking system, and the lack of information for applicants on the process for submission of ZaZiBoNa dossiers/applications in the individual countries, including contact details of the focal person. The establishment of a regional unit hosted in one of the member countries to centrally receive and track ZaZiBoNa dossiers/applications was identified as the best strategy for moving forward in the interim with the long-term goal being the establishment of a regional medicines authority.
There was consensus between the pharmaceutical industry and the regulatory authorities as to the way forward to improve the effectiveness and efficiency of the ZaZiBoNa initiative. Implementation of the recommendations identified in this study will lead to enhanced regulatory performance.
通用技术文档（CTD）格式统一了药品注册要求，而传统上各国的药品注册要求存在差异，这使得各国能够开展合作并对申请进行联合审评。南部非洲发展共同体的“ZaZiBoNa”就是这样一项药品注册合作倡议，于2013年设立。最近对“ZaZiBoNa”的九个活跃成员监管机构开展了一项研究，以确定它们对该倡议运作有效性和效率的看法。在获得这些监管机构的意见后，本研究的目的是评估“ZaZiBoNa”倡议当前运作模式的有效性和效率，包括其面临的挑战，并从申请人的角度找出改进机会。
招募了在2017年至2021年期间根据“ZaZiBoNa”倡议提交注册/上市许可申请以供审评的申请人参与本研究。2021年使用作者开发的流程、有效性和效率评级问卷（PEER-IND）收集数据。问卷由各公司负责提交“ZaZiBoNa”申请的代表填写。
制药行业认为，“ZaZiBoNa”倡议缩短了药品审批时间，使南部非洲发展共同体地区的患者能够更快获得质量有保证的药品。注册要求的统一和联合审评减轻了制药行业和监管机构的工作量。发现的一些挑战包括缺乏集中提交和跟踪系统，以及在各个国家缺乏向申请人提供有关提交“ZaZiBoNa”档案/申请流程的信息，包括联络人的联系方式。在一个成员国设立一个区域单位，以集中接收和跟踪“ZaZiBoNa”档案/申请，被确定为中期推进的最佳策略，长期目标是建立一个区域药品管理局。
制药行业和监管机构在如何提高“ZaZiBoNa”倡议有效性和效率的前进方向上达成了共识。实施本研究中确定的建议将提高监管绩效。
