Abstract
BackgroundThe aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices.MethodsA questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs).ResultsCurrently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future.ConclusionsAs the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.
Highlights
As part of a multicountry study on effective drug regulation, the World Health Organization (WHO) described 4 dimensions of medicine regulation, namely, administrative elements, regulatory functions, level of regulation, and technical elements.[1]
This study has evaluated the current Medicines Control Council (MCC) regulatory review process, as it has been applied prior to the establishment of South Africa Health Products Regulatory Authority (SAHPRA)
Key milestones and timelines within the regulatory review process have been identified and the measures used for good review practices (GRevPs) have been considered
Summary
As part of a multicountry study on effective drug regulation, the World Health Organization (WHO) described 4 dimensions of medicine regulation, namely, administrative elements, regulatory functions, level of regulation, and technical elements.[1]. The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. Methods: A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). The MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. It is hoped that resource constraints may be alleviated and capacity developed to meet target timelines
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