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T-36: The South African Regulatory Environment: Challenges and Opportunities for a Reformed Regulatory Review Process

Poster Presenter

Andrea Julsing Keyter

Deputy Director, Medical Devices
South African Health Products Regulatory Authority
South Africa

Objectives

This study aims to reflect upon the new regulatory environment in South Africa and the prioritised improvement of the regulatory performance of the Medicines Control Council (MCC) as it transitions to the South African Health Products Regulatory Authority (SAHPRA).

Method

A questionnaire was completed by the Head of the Agency to describe the organisational structure, the registration process, good review and decision-making practices within the MCC. Similar questionnaires were completed and validated by the agencies in Australia, Canada, Singapore and Switzerland.

Results

A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and procedures for medicine evaluation. The MCC conducted a full review of all applications however they did not place any reliance on reviews performed by other NRAs and as such do not make use of abridged or verification reviews. Other agencies conduct a full review and in addition to abridged or verification reviews. The median approval times (calendar days) for full reviews by Australia, Canada, Switzerland, Singapore and South Africa for 2015 were 373, 355, 464 and 1161, for 2016 were 369, 351, 481 and 1678 and for 2017 were 364, 350, 470 and 1422 respectively. Data from Singapore was not included as they mostly conduct abridged reviews. This study identified the Good Review Practices (GRevP) including the quality measures, transparency and communication parameters, continuous improvement initiatives and training and education that have been implemented by the five NRAs in order to enhance the regulatory review process. The five NRAs in this study implemented the majority of the essential elements of GRevP. The MCC differs in that there is no dedicated quality department, internal quality audits were not performed, applicants were unable to track the progress of their applications and the summary basis of approval of medical products was not published. These elements need to be addressed in order to strengthen the regulatory systems in South Africa. Legislative changes enacted in 2017 allowed for the transition of the MCC to SAHPRA. This re-form enables the new organisation to move forward with a framework for reliance and recognition, opportunities to implement facilitated regulatory pathways, improve quality management systems, initiate a new fee structure and advanced document management system as well as prioritise regulatory performance and timelines.

Conclusion

This study identified the challenges and opportunities for improvement as the MCC transitions to SAHPRA. These include the implementation of facilitated regulatory pathways, targets for key milestones in the regulatory review as well as the implementation and monitoring of GRevP. Formalising a quality management system would streamline the implementation of GRevP including quality decision-making and benefit-risk assessment. Systematic metrics collection of approval times and key milestones will support the measurement of key performance indicators and their continuous improvement. A risk-based approach to the evaluation of medical products will enhance the appropriate allocation of resources, reduce duplication of regulatory effort by utilising reliance and recognition mechanisms. Stakeholder relationships and communication may be enhanced through the application of an electronic document management system and the development of publicly available summaries for the basis of approval of medical products. A structured programme for the provision of ongoing training and skills development of internal regulatory reviewers as well as concomitant mentorship programmes are essential to fulfil the requirements of enhanced regulatory performance. These recommendations endorse SAHPRA’s vision for improved performance, transparency, consistency and accountability. With the newly established SAHPRA it is hoped that enhanced regulatory systems will support access and availability of quality, safe and effective health care products in South Africa.