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;9:898743. doi: 10.3389/fmed.2022.898743. eCollection 2022.
ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active members. While the successes of ZaZiBoNa are evident, some challenges still exist. The aim of this study was to solicit the views of the participating authorities on the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative.
Data were collected in 2021 using the Process, Effectiveness and Efficiency Rating (PEER) questionnaire developed by the authors. The questionnaire was completed by the focal person in each country and approved by the head of the authority.
ZaZiBoNa serves as a platform for work sharing, information exchange, capacity building and harmonisation of registration requirements. One of the benefits to regulators has been the improvement in the capacity to conduct assessments. Manufacturers have benefited from compiling one package (modules 2-5) for the initial submission as well as a single response package to the consolidated list of questions, which saves time and resources. Respondents were of the view that patients have benefited as the ZaZiBoNa has contributed to an improved availability and accessibility to quality-assured medicines. Some of the challenges identified were the inadequacy of resources and differences in time to the implementation of ZaZiBoNa recommendations by the individual countries. The establishment of a regional unit hosted in one of the member countries to enable centralised submission and coordination was identified as the best strategy to improve the effectiveness and efficiency of the initiative in the interim, with the long-term goal being the establishment of a regional medicines authority.
The study identified the strengths of the ZaZiBoNa initiative as well as the opportunities for improvement. The recommendations made would further strengthen this initiative.
“ZaZiBoNa”是南部非洲发展共同体（SADC）的工作共享倡议，已实施8年，成功评估了300多份档案/申请，总体推荐中位时间为12个月。南部非洲发展共同体的所有16个国家均作为活跃或非活跃成员参与该倡议。虽然“ZaZiBoNa”的成功显而易见，但仍存在一些挑战。本研究的目的是征求参与当局对“ZaZiBoNa”倡议当前运营模式的有效性和效率的意见。
2021年使用作者开发的流程、有效性和效率评级（PEER）问卷收集数据。问卷由每个国家的联络人填写，并经当局负责人批准。
“ZaZiBoNa”是一个工作共享、信息交流、能力建设和注册要求协调的平台。对监管机构的好处之一是评估能力得到了提高。制造商受益于编制一份初始提交的综合文件包（模块2 - 5）以及对综合问题清单的单一回复文件包，这节省了时间和资源。受访者认为患者也从中受益，因为“ZaZiBoNa”有助于提高优质药品的可获得性和可及性。发现的一些挑战包括资源不足以及各国在实施“ZaZiBoNa”建议的时间上存在差异。在一个成员国设立区域单位以实现集中提交和协调被认为是在过渡期间提高该倡议有效性和效率的最佳策略，长期目标是建立一个区域药品管理局。
该研究确定了“ZaZiBoNa”倡议的优势以及改进的机会。提出的建议将进一步加强这一倡议。
