The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland
The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland
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南非药品管制理事会：与澳大利亚、加拿大、新加坡和瑞士注册程序的比较
DOI：
10.3389/fphar.2019.00228
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发表时间：
2019-03-14
影响因子：
5.6
通讯作者：
Walker, Stuart
中科院分区：
文献类型：
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作者：
Keyter, Andrea;Salek, Sam;Walker, Stuart
简介：对规模和监管特点类似的监管机构进行比较，有助于制定增值基准，并有助于深入了解监管绩效。随着当局朝着实现其监管目标和利益相关者的要求迈进，这种比较突出了需要改进的领域。本研究的目的是将南非药品控制理事会（MCC）的注册流程和监管审查模式与其他四个类似规模的监管机构进行比较，并确定需要改进的领域，以便向南非保健品监管局（SAHPRA）提出建议，因为它希望重新设计和加强南非的注册流程。方法：为了本研究的目的，作者（AK）填写了一份调查表，其中描述了管理挑战委员会的组织结构、登记程序、良好审查和决策做法，并得到管理挑战委员会登记官的确认。类似的问卷调查也完成了澳大利亚的治疗用品管理局（TGA），加拿大卫生部，新加坡的健康科学管理局（HSA）和瑞士的Swissmedic.Results验证：MCC监管过程与四个比较机构的比较表明，他们都有类似的要求，并采用全面审查模式，虽然MCC的时间表相当长。然而，所有主管部门都实施了类似的质量措施，作为其良好审查做法的一部分，包括优先考虑透明度、沟通、持续改进举措和培训。通过本研究进行的比较提供了对MCC注册过程中可以改进的领域的深入了解，并为SAHPRA提供了知情建议，包括实施便利的监管途径，定义监管审查和正式实施及监测GRevP的关键里程碑的目标。为了提高审评过程的质量，可以考虑应用标准化的药物临床评估模板，如获益-风险评估通用方法（UMBRA），并通过应用电子管理系统和编制公开的批准基础摘要来提高透明度和沟通。
Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders' demands. The aims of this study were to compare the registration process and the regulatory review model of the South African Medicines Control Council (MCC) to that of four other similarsized regulatory authorities and to identify areas for improvement that may inform recommendations to the South African Health Products Regulatory Authority (SAHPRA) as it looks to re-engineer and enhance the registration process in South Africa.Methods: A questionnaire describing the organisational structure, the registration process, good review and decision-making practices of the MCC was completed by the author (AK) for the purpose of this study and validated by the Registrar of the MCC. Similar questionnaires were also completed and validated by Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada, Singapore's Health Science Authority (HSA) and Switzerland's Swissmedic.Results: A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and employ a full-review model although the timelines for the MCC were considerably longer. However, similar quality measures were implemented by all authorities as part of their good review practices (GRevP) including prioritising transparency, communication, continuous improvement initiatives and training.Conclusion: Comparisons made through this study provided insight into the areas of the MCC registration process that may be improved and have informed recommendations to SAHPRA including the implementation of facilitated regulatory pathways, definition of targets for key milestones in regulatory review and formal implementation and monitoring of GRevP. In order to build quality into the review process the application of a standardised template for the clinical assessment of medicines such as the Universal Methodology for Benefit-Risk Assessment (UMBRA) could be considered as well as enhancing transparency and communication through the application of an electronic management system and the development of publicly available summaries for the basis of approval.