The South African Regulatory System: Past, Present, and Future.

Andrea Keyter,Stuart Walker,Shabir Banoo,Sam Salek

doi:10.3389/fphar.2018.01407

Abstract

The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decision-making practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.

Highlights

Ensuring effective medicine regulation through the strengthening of regulatory systems and improvement of regulatory performance has become a priority for both national regulatory authorities (NRAs) and governments worldwide
Global trends toward increased pressure on NRAs of all sizes and capacity due to the increased volumes of applications received, the complexity of the submissions and the increased number of categories of medical products have been noted (World Health Organization [WHO], 2014a). These trends and statistics resonate with many NRAs in low- and middleincome countries that have historically been faced with resource constraints (World Health Organization [WHO], 2014b) and that have not participated in global harmonization initiatives or development programs aimed at strengthening regulatory systems (Preston et al, 2012)
NRAs have been encouraged by the WHO to consider regulatory convergence and to collaborate with and recognize work done by other regulators to ease the regulatory burden (Ward, 2014; World Health Organization [WHO], 2014b)

Summary

INTRODUCTION

Ensuring effective medicine regulation through the strengthening of regulatory systems and improvement of regulatory performance has become a priority for both NRAs and governments worldwide. Prior to the establishment of SAHPRA in February 2018 the MCC was the national medicines regulatory authority of South Africa responsible in terms of the Act to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of human and veterinary medicines, scheduled substances, clinical trials and related matters in the public interest. The introduction of a registration procedure in 1968 meant that all medicines intended for sale in South Africa were evaluated and approved by the Drugs Control Council prior to entering the market. Over the three decades the legislative framework and regulatory requirements were amended several times to reflect the intentions of the regulatory authority as it strived toward improved control of medicines in South Africa. Conditions prohibiting the sale of any medicine, which were subject to registration, and which were not registered, were defined

A Pricing Committee for medicines was established

Result

Findings

CONCLUSION